Hcc - Hepatocellular Carcinoma

This is a prospective, single-arm, single-center exploratory clinical study designed to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with QL1706 in patients with hepatocellular carcinoma who have received one prior line of systemic therapy and experienced radiographic disease progression or intolerance. Eligible patients will receive SBRT to all evaluable intrahepatic lesions at a total dose of 25-50 Gy delivered in 5 fractions. Within 7-14 days after completion of SBRT, patients will receive QL1706 at 7.5 mg/kg by intravenous infusion every 3 weeks. Treatment with QL1706 will continue until confirmed disease progression, intolerable toxicity, patient request to withdraw, withdrawal of informed consent, or other protocol-defined treatment discontinuation criteria, whichever occurs first. The primary endpoint is objective response rate assessed by the investigator according to modified RECIST criteria. Secondary endpoints include local control rate of SBRT target lesions, progression-free survival, overall survival, disease control rate, and the incidence of adverse events and serious adverse events. Exploratory endpoints include dynamic changes in serum tumor biomarkers and immune-related indicators, as well as their association with clinical outcomes. A total of 36 patients are planned for enrollment.

By comparing the diagnostic accuracy of spectral CT and conventional CT in evaluating treatment response efficacy after TACE, this study aims to investigate the diagnostic performance of spectral CT in assessing treatment response following TACE for hepatocellular carcinoma.

The purpose of this study is to evaluate the comprehensive therapeutic efficacy and safety profile of the epalrestat combined with hepatic artery infusion chemotherapy (HAIC), donafenib and tislelizumab quadruple regimen in patients with unresectable hepatocellular carcinoma (HCC) and diabetes.

This study aims to explore the value of the 'HAIC Apatinib Camrelizumab' triple regimen for perioperative treatment of resectable hepatocellular carcinoma. The study adopts a multicenter, randomized, open-label, controlled design and plans to enroll 208 patients, randomly assigned 1:1 to the experimental group and the control group. The experimental group will receive preoperative HAIC combined with targeted-immunotherapy triple regimen neoadjuvant therapy, followed by radical resection, and continue postoperative adjuvant therapy; the control group will undergo surgery directly. The primary endpoint is EFS, and secondary endpoints include R0 resection rate, pCR, MPR, OS, and 1-year/2-year/3-year EFS rates.

This study adopted a bidirectional cohort study design. On the one hand, the previous clinical data, treatment exposure and clinical endpoint events of the enrolled patients were retrospectively collected. On the other hand, prospective regular follow-up was conducted from the date of enrollment to continuously observe long-term recurrence, progression and survival outcomes, and analyze the correlation between related factors and prognosis. The primary objective of this study was to describe the efficacy and safety of SIRT-Y90 in combination with atezolizumab and bevacizumab in adult patients with unresectable HCC in China. Medical records from approximately eight sites in China will be used.

We explored the efficacy and safety of the first-line treatment of unresectable hepatocellular carcinoma with donafenib combined with hepatic artery infusion chemotherapy (HAIC) and sintilimab .

This study is being done to help doctors improve how they treat liver tumors that cannot be removed by surgery or treated with standard ablation techniques. The researchers want to find out the best amount of radiation that needs to be delivered to completely destroy (or ablate) parts of the liver that have cancer.

The goal of this study is to test whether providing various social resources (transportation support through Lyft rides, housing support through Hyatt House LA, and meal support through Project Angel Food LA) will reduce treatment delays and increase treatment uptake for patients with liver cancer.

Conversion therapy for unresectable intermediate-advanced hepatocellular carcinoma (uHCC) has evolved from systemic therapy to combined local-systemic approaches, but current regimens still have limited surgical conversion rates. This prospective, single-arm phase II study evaluates a combination regimen of PD-1 inhibitor (sintilimab) plus CTLA-4 inhibitor (ipilimumab N01), bevacizumab biosimilar, and HAIC for patients with initially unresectable intermediate-advanced HCC. The primary goal is to achieve a higher surgical conversion rate with manageable safety

This is a single-arm, open-label Phase IIa study designed to evaluate the efficacy, safety, and PK of CVM-1118 in combination with Sintilimab (Tyvyt ®) and TACE in participants with incurable/non-metastatic HCC. Approximately 40 participants will be enrolled, all receiving CVM-1118 (200 mg orally \[PO\], twice daily \[BID\]) in combination with Sintilimab (200 mg via intravenous \[IV\] infusion every 3 weeks \[Q3W\]) and TACE. All participants will initiate treatment with CVM-1118 and Sintilimab on Cycle 1 Day 1 (C1D1), with each cycle lasting 21 days, continuing until the occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, for 2 years (i.e., Cycle 34) or study termination (whichever occurs first). CVM-1118 will be temporarily suspended from 2 days prior to each TACE procedure until 7 days post-TACE. The protocol permits conventional TACE (cTACE) or drug-eluting beads TACE (DEB-TACE) based on investigator's discretion, with the requirement that each participant maintains the same TACE modality throughout the treatment period. The first TACE procedure will be initiated between weeks 2-4 (C1D15 - C2D8) following systemic therapy initiation, with a maximum of 2 TACE treatments per lesion, an interval of ≥1 month between TACE sessions, and no more than 4 TACE treatments in total per participant. The study comprises four periods: screening, treatment, safety follow-up, and survival follow-up. During the screening period, participants will undergo required examinations and evaluations. Eligible participants will enter the treatment period to receive the combination regimen. Tumor response will be assessed per RECIST v1.1 and mRECIST (see Appendix 1), with evaluations conducted every 9 weeks (±1 week) following initial dosing. During the safety follow-up period, all participants will undergo final safety assessments 28 days (+7 days) after investigational product cessation or prior to initiating new antitumor therapy. Subsequently, participants will enter the survival follow-up period with 12-week interval contacts to document disease status, anti-tumor therapies received, survival status, and other relevant clinical information until death, loss to follow-up, consent withdrawal, or study closure (whichever occurs first). Throughout the study, participants will undergo scheduled safety evaluations and PK blood sampling at designated timepoints. Subsequent PK sampling schedules may be adjusted or eliminated based on accumulated pharmacokinetic data from preceding participants. * CVM 1118 will be administered at 200 mg, PO, BID. Treatment continues until unacceptable toxicity, disease progression, death, consent withdrawal, for 2 years (i.e., Cycle 34), or study termination (whichever occurs first). CVM-1118 will be temporarily suspended from 2 days prior to each TACE procedure until 7 days post-TACE. CVM-1118 should be swallowed whole with a glass of water in a fasted state, with no food intake for at least 2 hours before and 1 hour after CVM 1118 administration. CVM 1118 should be administered at approximately the same time each day. Investigators are permitted to adjust the dosing for participants as required by referring to the "Dose Adjustment". * Sintilimab will be administered at 200 mg, IV, Q3W. Treatment continues until unacceptable toxicity, disease progression, death, consent withdrawal, for 2 years (i.e., Cycle 34) or study termination (whichever occurs first). Investigators are permitted to adjust the drug administration regimen for participants as required by referring to the "Dose Adjustment". * TACE modality for each participant, including the choice between cTACE and DEB-TACE, will be determined by investigators at their discretion; however, each participant must remain consistent with the selected TACE modality (cTACE or DEB-TACE) throughout the treatment period. The first TACE procedure will be initiated 2-4 weeks after the start of systemic therapy (C1D15 to C2D8), with a maximum of 2 treatments per lesion (minimum 1-month interval between TACE sessions) and up to 4 treatments per participant in total.

This study aims to evaluate the effectiveness and safety of a combination therapy with Fuxinqibai monoclonal antibody, Tislelizumab, and Lenvatinib in patients with advanced, unresectable TP53-mutated hepatocellular carcinoma (HCC) who have previously failed systemic immunotherapy. Eligible patients will receive: Fuxinqibai 200 mg IV every 3 weeks Tislelizumab 200 mg IV every 3 weeks Lenvatinib 8 mg (≤60 kg) or 12 mg (\>60 kg) orally once daily Treatment will continue until disease progression, unacceptable toxicity, start of a new anticancer therapy, withdrawal of consent, or other protocol-defined reasons. Tumor response will be evaluated by RECIST v1.1 every 6 weeks, and confirmed after 4 weeks if response is observed. Safety will be monitored through adverse events and laboratory tests, graded according to NCI CTCAE v5.0. After treatment ends, patients will be followed every 6 weeks for tumor assessment and every 12 weeks for survival, until death, loss to follow-up, or withdrawal of consent. Primary Objective: To assess the objective response rate (ORR) of the combination therapy. Secondary Objectives: To evaluate overall efficacy, safety, and explore potential biomarkers predicting treatment response.

Postoperative recurrence remains a major limitation to long-term survival in hepatocellular carcinoma (HCC). In addition, a narrow surgical margin is widely regarded as a risk factor for recurrence. Neoadjuvant therapy may represent a strategy to reduce the risk of recurrence, thereby improving long-term outcomes. Tislelizumab plus lenvatinib has demonstrated promising efficacy with manageable safety in advanced HCC. Therefore, we will conduct a phase II study to compare neoadjuvant tislelizumab plus lenvatinib followed by surgery versus surgery alone in patients with stage IA HCC and an anticipated narrow surgical margin.

This study aims to investigate the efficacy and safety of neoadjuvant therapy with Iparomlimab and Tuvonralimab Injection (anti-PD-1 and anti-CTLA-4 antibody combination) in patients with resectable hepatocellular carcinoma at high risk of recurrence (Stage IB, Stage IIA).

This study is a multicenter retrospective clinical research, led by the First Affiliated Hospital of Wenzhou Medical University, and jointly conducted by other sub-centers. The aim is to develop an non-invasive artificial intelligence system for predicting the response and clinical outcomes of patients with unresectable hepatocellular carcinoma (uHCC) to the treatment with atezolizumab combined with bevacizumab (T+A). In response to the clinical situation where approximately half of uHCC patients do not respond to the standard T+A therapy and traditional invasive biopsy is unable to fully reflect the heterogeneity of the tumor microenvironment, this study plans to retrospectively collect the data of 400 patients who met the inclusion and exclusion criteria from January 2020 to November 2025. The study will systematically summarize multi-dimensional data such as enhanced CT images within one month before treatment, baseline characteristics, serum markers, liver disease factors, and tumor stage. By integrating these clinical features with deep learning imageomics features extracted from images, the research team is dedicated to constructing and validating a safe, non-invasive, and reproducible prediction model, with the aim of achieving precise identification of the benefit population before implementing immunotherapy combined with anti-angiogenic treatment, and providing a powerful intelligent tool support for optimizing clinical treatment decisions and improving patient survival prognosis.

This is a prospective, multicenter, randomized controlled, phase 3 study to explore the efficacy and safety of neoadjuvant tislelizumab plus lenvatinib in patients with resectable HCC at high risk of recurrence.

Radiotherapy is increasingly being used in the management of hepatocellular carcinoma (HCC) as a standalone treatment, or in combination with systemic therapy. Stereotactic Body Radiation Therapy (SBRT) causes cell death directly (via double-stranded breaks) and indirectly (via vascular bed damage or promotion of antitumour immunity). Unfortunately, the effect of cell death is not immediate and takes time. As a result, the typical arterial phase hyperenhancement on imaging may persist up to 12 months after radiotherapy, and it is not necessarily suggestive of presence of viable tumours. Therefore, there is no consensus on ideal timing of response assessment following radiotherapy to HCC. Therefore, a blood-based biomarker which can be done frequently and monitored dynamically, could be preferred for response assessment after radiotherapy. Circulating tumour DNA (ctDNA) is an emerging and promising biomarker in cancer management, which has been shown useful in cancer screening, guiding treatment, and informing prognosis. Currently, most of the clinical applications of ctDNA revolve around either the presence of ctDNA, or the genomic changes associated with these molecules. Biological properties of ctDNA such as fragment length, jaggedness of fragments, or epigenetic changes may provide additional information related to the tumour characteristics and its sensitivity to anti-cancer treatments. These biological properties of ctDNA are relatively unexplored in the context of radiotherapy. It is unknown whether these properties can be utilized for monitoring treatment response. We therefore propose to study the biological properties of ctDNA in relation to HCC patients undergoing radiotherapy.

The "Surgery versus Maintenance after Conversion-therapy-achieved Complete/Partial Response in Hepatocellular Carcinoma (SWITCH)" study is a multicenter, open-label, prospective non-randomized cohort study with the protocol number SWITCH-01 (Version 0.1, dated October 5, 2025). Sponsored by West China Hospital of Sichuan University and led by Principal Investigator Wu Hong, the study involves 10 participating centers and has completed NCT registration. Its core objective is to evaluate and compare the efficacy and safety of two management strategies-surgical resection and maintenance therapy-in patients with hepatocellular carcinoma (HCC) who have achieved complete response (CR) or partial response (PR) after conversion therapy and are deemed eligible for curative liver resection (R0) by a multidisciplinary team (MDT). The study is designed to address the clinical dilemma of optimal management for initially unresectable HCC patients who attain favorable responses to conversion therapy, providing high-level evidence for clinical decision-making.

The goal of this clinical trial is to learn whether adding branched-chain amino acids (BCAAs) to lenvatinib and pembrolizumab improves treatment outcomes in adults with unresectable hepatocellular carcinoma (HCC). The study will also evaluate the safety of this combination treatment. The main questions this study aims to answer are: Does the addition of BCAAs improve the time patients live without their cancer getting worse? Does the combination treatment improve tumor response compared with standard treatment alone? What medical problems or side effects do participants experience during treatment? Researchers will compare lenvatinib plus pembrolizumab with BCAAs to lenvatinib plus pembrolizumab alone to see whether adding BCAAs provides additional benefit for patients with unresectable HCC. Participants will: Be randomly assigned to receive lenvatinib and pembrolizumab with or without oral BCAAs Take lenvatinib by mouth every day and receive pembrolizumab by intravenous infusion every 3 weeks Continue treatment until disease progression, unacceptable side effects, or withdrawal from the study Visit the clinic regularly for physical examinations, imaging tests, blood tests, and safety assessments

This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary antitumor activity of TGI-5 as monotherapy and in combination with Nivolumab in subjects with unresectable locally advanced/metastatic solid tumors. The study consists of two parts: TGI-5 monotherapy (Phase 1a: including a dose escalation part and a dose expansion part), TGI-5 in combination with a fixed dose of Nivolumab (Phase 1b: including a dose escalation part and a dose expansion part).

The goal of this clinical trial is to learn if INT001 can ablate liver tumors in adults in an outpatient setting. It will also help us learn about the safety of INT001. The main questions it aims to answer are: 1. Using a needle under image guidance, the liver tumor is accessed and INT001 is injected. Upon injection into tumor, does INT001 ablate/kill the tumor entirely? 2. What medical problems do participants experience when receiving INT001? Participants will: Receive INT001 on day 1. Visit the clinic day 7, 30 and 90. Receive lab tests during each visit and MRI on day 30 and 90.

For HCC patients with PVTT who the researchers believe can benefit from radiotherapy combined with tislelizumab and anlotinib, informed consent forms will be signed, and then they will receive the study treatment and be followed up. The research design is as follows: First, radiotherapy was administered. Three days ±1 day after the start of radiotherapy, tislelizumab and anlotinib treatment were initiated. Each cycle was three weeks, and the treatment continued until no toxicity was acceptable or clinical benefits were lost (evaluated by the researcher based on imaging, biochemical indicators, and the patient's clinical status).

The goal of this clinical trial is to learn if drug AST-3424 works to treat AKR1C3 high expressing advanced hepatocellular carcinoma after failure of systemic therapy with immune checkpoint inhibitors. The main question it aims to answer is: Does AST-3424 prolong survival in patients with AKR1C3-high Expressing advanced Hepatocellular Carcinoma who have progressed after immune checkpoint inhibitors based therapies? Researchers will compare AST-3424 to regorafenib (current optional therapy for target patients) to see if AST-3424 works. Participants will: Receive AST-3424 infusion on Day 1 and Day 8 of each 21-day treatment cycle or take regorafenib once a day on Day 1 -Day 21 of each 28-day treatment cycle.

On the basis of previous studies, this study intends to explore the efficacy of preoperative oral administration of Lactobacillus reuteri (Lr) combined with preoperative neoadjuvant/conversion therapy in patients with primary resectable hepatocellular carcinoma (HCC). We hypothesize that this combination represents a novel, microbiota-based therapeutic strategy to facilitate perioperative hepatic recovery and improve long-term survival outcomes. This study is an open-label, randomized, blank-controlled clinical trial. Patients undergoing liver resection were randomly allocated to one of two groups. The intervention group received preoperative oral Lactobacillus reuteri (Lr) supplementation alongside neoadjuvant/conversion immunotherapy. The control group received preoperative neoadjuvant/conversion immunotherapy alone. Fecal and peripheral blood samples will be collected at baseline (pre-medication), 3 days prior to surgery, and at 5 days, 1, 3, 6, 9, 12, 18, and 24 months postoperatively. Intraoperative liver tissue samples will also be obtained. Statistical analyses will be performed to compare intergroup differences in postoperative liver function recovery, overall survival, hepatic and peripheral immune markers, and gut microbiota composition. This study aims to develop adjuvant strategies to enhance therapeutic outcomes for HCC patients undergoing preoperative neoadjuvant/conversion immunotherapy.

Hepatocellular carcinoma (HCC) is one of the commonest cancers worldwide and ranks the third on the incidence of cancer-related death. There are more than 500000 new cases diagnosed annually worldwide. The incidence and prevalence of HCC are on rising trend with the majority of the disease burden is in Asia where viral hepatitis B is endemic. Surgical resection, radiofrequency ablation (RFA) and liver transplantation (LT) represent the only chance of cure for HCC patients. Despite more aggressive surgical approach has been adopted in most Asian countries, yet curative intervention remains only amendable in 30% of patients. Most patients are diagnosed with intermediate or advanced stage diseases; the long-term cure rate is only 0-10%. Hence, every effort has been made in an attempt to convert inoperable HCC into operable disease (i.e. downstaging) in order to improve the chance of survival of these patients. The current study, to our knowledge, will be the first study in the field to deploy a novel treatment strategy to deploy both immunotherapy and stereotactic beamed radiotherapy to induce tumor shrinkage rendering it become operable cancer.

This research plan involves a treatment approach for advanced hepatocellular carcinoma (HCC) in the context of metabolic-associated steatotic liver disease (MASLD). The study aims to compare the efficacy differences between sequential therapy and concurrent therapy using bevacizumab and atezolizumab for advanced HCC in MASLD. The research will focus on evaluating objective response rates, progression-free survival, disease control rates, and overall survival, while utilizing biomarker analysis to elucidate treatment mechanisms. Additionally, the study will examine treatment safety, including the incidence and severity of adverse events.