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Recruiting NCT07147101

Different First-line Immunotherapy for Advancer Hepatocellular Carcinoma: A Prospective Observational Study on Efficacy and Immune Microenvironment

— Observational Advanced Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sintilimab, Bevacizumab Biosimilar, Camrelizumab, Rivoceranib.
Who it may be relevant to
Registry conditions: Advanced Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Non-interventional Study of Different First-line Immunotherapy in Advanced Hepatocellular Carcinoma Patients: Efficacy and Immune Microenvironment Dynamics

Overview

To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy.

Detailed description

This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy, including anti-PD1+anti-VEGF, anti-PD1+TKI and anti-PD1+anti-CTLA4. The primary endpoint is objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and immune profiling of tumor tissue and peripheral blood before and after treatment.

Interventions

  • Drug Sintilimab
    Sintilimab will be administered by IV, 200 mg every 3 weeks
  • Drug Bevacizumab Biosimilar
    Bevacizumab biosimilar will be administered by IV, 15 mg/kg every 3 weeks.
  • Drug Camrelizumab
    Camrelizumab will be administered by IV, 200 mg every 2 weeks.
  • Drug Rivoceranib
    Rivoceranib will be administered by oral 250 mg once daily.
  • Drug Nivolumab
    Nivolumab will be administered by IV, 1 mg/kg every 3 weeks for up to four doses, followed by nivolumab 480 mg every 4 weeks
  • Drug Ipilimumab
    Ipilimumab will be administered by IV, 3mg/kg every 3 weeks for up to four doses.

Primary outcome measures

  • Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: max 24 months]
Secondary outcome measures (7)
  • Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: max 24 months]
  • Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: max 24 months]
  • Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: max 24 months]
  • Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: max 24 months]
  • Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: max 42 months]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: max 42 months]
  • Translational study [Time frame: max 24 months]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years at time of study entry.
  • Barcelona Clinic Liver Cancer stage C, or stage B not amenable to curative or locoregional therapies.
  • HCC confirmed by radiology, histology or cytology.
  • No prior systemic therapy for HCC.
  • At least one measurable site of disease as defined by RECIST1.1criteria with spiral CT scan or MRI.
  • Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale).
  • Adequate organ function:
  • ANC ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥9 g/dL.
  • Total bilirubin ≤1.5 × ULN, AST/ALT ≤3 × ULN (≤5 × ULN if liver metastases).
  • Creatinine ≤1.5 × ULN or CrCl ≥60 mL/min.
  • Willing to provide archival/fresh tumor tissue and peripheral blood samples.
  • Signed informed consent.

Exclusion criteria

  • Prior systemic therapy for HCC
  • Active autoimmune disease requiring immunosuppression.
  • Active infection requiring IV antibiotics.
  • HIV-positive or active HBV/HCV infection (HBsAg+ with HBV DNA ≥2000 IU/mL; HCV RNA+).
  • Symptomatic CNS metastases.
  • Pregnancy/lactation.
  • Any condition compromising protocol compliance or data interpretation per investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT07147101 · HCC-IM-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗