Multimodal Thermal Therapy With Targeted and Immunotherapy for Untreated Unresectable HCC

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhejiang University

About this trial

Multimodal Thermal Therapy combined with targeted therapy and immunotherapy versus targeted therapy and immunotherapy alone for systemically untreated unresectable hepatocellular carcinoma (HCC)

Eligibility criteria

Qualifiers

• Age 18-80, regardless of gender;

Diagnosed with unresectable HCC by imaging or histology, BCLC stage B or C;

No prior systemic immunotherapy, chemotherapy, targeted therapy, or other systemic drug treatments for HCC;

Presence of an image-evaluable lesion intended for ablation without prior local ablation therapy, with the maximum diameter of the target tumor ≤5 cm;

Disqualifiers

• Invasion of the main portal vein;

Diffuse hepatocellular carcinoma;

Patients with a history or current diagnosis of brain metastases whose symptoms are not fully controlled (i.e., persistent or worsening symptoms, or requiring adjustments to symptomatic treatment to maintain symptom relief);

Extensive distant metastasis confirmed by imaging (e.g., chest/abdominal CT/MRI, whole-body bone scan, PET-CT, etc.), including but not limited to diffuse lung metastasis, multiple bone metastases, extensive abdominal/peritoneal metastasis, or other multi-organ metastases, where the investigator assesses that the extent of metastasis may compromise the safe administration of study treatment or affect efficacy and safety evaluations;

Trial design

Treatments tested in this trial

  • Multimodal Thermal Therapy
  • Targeted and Immune Drugs

Treatment groups

166 Participants
are divided into 2 treatment groups

Locations

4
Huaihe Hospital of Henan University KaifengHenan, China
The Second Affiliated Hospital of Nanchang University NanchangJiangxi, China
The First Affiliated Hospital, Zhejiang University School of Medicine HangzhouZhejiang Provinece, China
The Fourth Affiliated Hospital, Zhejiang University School of Medicine YiwuZhejiang Provinece, China

Sponsors and collaborators

Zhejiang University

Lead sponsor