Comparing first-line immunotherapy combinations for advanced liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, non-interventional observational study follows patients with advanced hepatocellular carcinoma who start one of several first-line immunotherapy combinations (anti‑PD‑1 plus anti‑VEGF, anti‑PD‑1 plus a TKI, or anti‑PD‑1 plus anti‑CTLA‑4). Treatment choice is made by the treating physician and the study collects imaging, clinical outcomes, and biospecimens without assigning interventions. The primary endpoint is objective response rate by RECIST 1.1, and secondary endpoints include disease control rate, duration and time to response, progression‑free survival, and overall survival. The protocol includes immune profiling of tumor tissue and peripheral blood before and after treatment to characterize changes in the tumor microenvironment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Peng Wang, MD
• Email: peng_wang@fudan.edu.cn
• Phone: 86-21-64041990

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dual-target GPC3 and B7-H3 CAR‑NK therapy for advanced liver cancer

  This trial will test an off‑the‑shelf CAR‑NK cell therapy that targets GPC3 and B7‑H3 in adults with advanced hepatocellular carcinoma who have progressed on or cannot take standard treatments.

  Recruiting Phase 1/2 Beijing Biotech · Shenzhen, Guangdong · NCT07500220

• Super CAR-T therapy for GPC3-positive advanced liver cancer

  This trial tests a single infusion of Super CAR-T cell therapy in adults with advanced, GPC3-positive hepatocellular carcinoma who have failed at least two standard treatments.

  Recruiting Phase 1 Guangzhou FineImmune Biotechnology Co., LTD. · Guangzhou, Gaungdong · NCT07493044

• Autologous neoantigen T-cell therapy for advanced liver cancer

  This treatment tries a personalized neoantigen-specific T-cell therapy for people with advanced hepatocellular carcinoma who have not responded to two or more systemic treatments.

  Recruiting Phase 1/2 Zhejiang University · Hangzhou, Zhejiang · NCT07123545

• CG-102-12C for GPC3-positive advanced liver cancer

  This will test whether a single infusion of CG-102-12C can help people aged 18–75 with GPC3‑positive advanced hepatocellular carcinoma who did not respond to standard systemic treatments.

  Recruiting Zhejiang University · Hangzhou, Zhejiang and 1 other locations · NCT07039201

• Personalized mRNA therapy for advanced liver cancer

  This study is testing a new personalized mRNA therapy combined with other treatments to see if it can help people with advanced liver cancer feel better.

  Recruiting Phase 1/2 Zhejiang University · Hangzhou, Zhejiang · NCT06995105

• Multi-target Hi-TCR-T cell therapy for advanced hepatocellular carcinoma

  This trial will test whether personalized multi-target Hi-TCR-T cell infusions can help people with advanced, treatment-refractory hepatocellular carcinoma.

  Recruiting Phase 1/2 Eastern Hepatobiliary Surgery Hospital · Shanghai, Yangpu District · NCT06902389

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.