TACE plus anti-PD-1 treatment 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 is a prospective, non-interventional observational study of patients with advanced hepatocellular carcinoma who are planned to receive transarterial chemoembolization (TACE) combined with an anti-PD-1 antibody as first-line therapy. The study will enroll treatment-naïve adults with measurable disease and ECOG 0–1 and will collect tumor tissue and peripheral blood before and after treatment for immune profiling. The primary endpoint is objective response rate (ORR) by mRECIST, with secondary endpoints including disease control rate, duration and time to response, progression-free survival, overall survival, and changes in the tumor and peripheral immune microenvironment. All treatments follow routine clinical care at the study site and no experimental interventions are administered by the protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years.
* BCLC stage C, and stage B who are not amenable to curative or locoregional therapies.
* Diagnosis of hepatocellular carcinoma.
* At least one measurable site of disease as defined by modified RECIST (mRECIST) criteria with spiral CT scan or MRI.
* No prior anticancer therapy, including TACE/HAIC, chemotherapy, targeted therapy, or immunotherapy).
* Planned to receive TACE plus anti-PD1 inhibitor as first-line treatment.
* ECOG performance status 0-1.
* Adequate organ function:
* ANC ≥1.5 × 10⁹/L, platelets ≥60 × 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.
* 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

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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.