Prognosis Stratification for Advanced HCC Receiving TACE with PD-1/PD-L1 Inhibitors and Molecular Target Therapies

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZhongda Hospital

About this trial

The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage hepatocellular carcinoma (HCC) receiving transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has a diagnosis of HCC confirmed by radiology, histology, or cytology;

Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread and/or macrovascular invasion;

Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);

Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;

Disqualifiers

Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;

Unable to meet criteria of combination timeframe described above;

Child-Pugh C or PS>2 or Severe hepatic encephalopathy

Trial population

Patients with advanced HCC who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Overall Survival(OS)

The OS is defined as the time from the initiation of any combination treatment to death due to any cause.

Time frame
up to approximately 2 years

Secondary outcomes

1

Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1) or death due to any cause, whichever occurs first.

Time frame
up to approximately 2 years
2

PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.

Time frame
up to approximately 2 years
3

Objective response rate(ORR) per RESCIST 1.1

The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.

Time frame
up to approximately 2 years
4

ORR per mRECIST

The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.

Time frame
up to approximately 2 years

Other outcomes

Sponsors and contacts

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