TACE plus anti-PD-1 treatment for advanced liver cancer

A Prospective, Non-interventional Study of TACE Combined With PD-1 Inhibitor in Patients With Advanced Hepatocellular Carcinoma: Efficacy and Immune Microenvironment Dynamics

This study will test whether combining TACE with a PD-1 blocker helps people with advanced hepatocellular carcinoma and how the treatment changes immune cells in tumors and blood.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07100405 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with BCLC stage C or stage B not amenable to curative/locoregional therapies, treatment‑naïve, with at least one mRECIST-measurable lesion, ECOG 0–1, adequate organ function, and willingness to provide tumor tissue and blood are ideal candidates.

Not a fit: Patients who received prior systemic therapy or TACE, have active autoimmune disease requiring immunosuppression, uncontrolled infections, or other active severe conditions (e.g., untreated viral infections) are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this work could identify whether the TACE plus PD-1 combination yields higher response rates and reveal immune biomarkers that predict who benefits.

How similar studies have performed: Other observational and early-phase studies combining locoregional therapy with PD-1 blockade have shown promising response signals, but randomized evidence is still limited.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Peng Wang, MD

Conditions: Hepatocellular Carcinoma