Immunotherapy plus anti‑VEGF drugs with or without TACE/HAIC for advanced liver cancer

Immune Checkpoint Inhibitors and Anti-Vascular Endothelial Growth Factor Antibody/Tyrosine Kinase Inhibitors With or Without Interventional Therapy for Advanced HCC

This trial will try combining immune checkpoint drugs and anti‑VEGF medication, with or without interventional liver procedures, to treat adults with advanced hepatocellular carcinoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07157969 on ClinicalTrials.gov

What this trial studies

This phase 2 trial compares two treatment approaches for advanced hepatocellular carcinoma: systemic immune checkpoint inhibitors combined with anti‑VEGF agents alone versus the same systemic regimen given together with interventional liver procedures (conventional or drug‑eluting TACE, or hepatic arterial infusion chemotherapy). Eligible participants are assigned to one of the two groups based on their treatment plan and receive medications such as pembrolizumab, camrelizumab, atezolizumab, bevacizumab, or lenvatinib alongside or without the interventional procedures. The number and timing of interventional sessions are individualized to each patient’s condition. Investigators will monitor safety and measure outcomes including objective response rate, disease control rate, progression‑free survival, overall survival, and duration of response.

Who should consider this trial

Good fit: Adults (≥18) with hepatocellular carcinoma stage B or C, ECOG 0–1, Child‑Pugh A or B, at least one measurable lesion by RECIST 1.1, adequate organ function, and who consent to receive immune checkpoint and anti‑VEGF therapy with or without interventional liver procedures are ideal candidates.

Not a fit: Patients eligible for curative liver resection or transplantation, pregnant or breastfeeding individuals, those with known allergy to PD‑1/PD‑L1 agents, or people with poor performance status or decompensated liver function are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could increase tumor shrinkage rates and extend progression‑free and overall survival for people with advanced HCC.

How similar studies have performed: Combinations of PD‑1/PD‑L1 inhibitors with anti‑VEGF therapy (for example atezolizumab plus bevacizumab) have shown clinical benefit in advanced HCC, and adding locoregional treatments like TACE/HAIC is an active area of research with promising early signals but not yet definitive evidence.

Eligibility criteria

Inclusion Criteria:

1. Subjects voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and are cooperative with follow-up.
2. Age ≥18 years at the time of signing informed consent, regardless of gender.
3. Diagnosis of hepatocellular carcinoma confirmed by imaging (according to AASLD criteria), histology, or cytology.
4. BCLC Stage B or C.
5. At least one measurable lesion per RECIST 1.1.
6. ECOG score of 0-1.
7. Child-Pugh liver function class A or B.
8. Life expectancy ≥ 3 months.
9. Adequate hematological and organ function.

Exclusion Criteria:

1. Patients with hepatocellular carcinoma who are candidates for surgical radical cure, or have undergone radical surgery without evaluable lesions, or have a history of or are planned for liver transplantation.
2. Pregnant or breastfeeding women.
3. Individuals with known allergy or intolerance to recombinant humanized PD-1/PD-L1 monoclonal antibody preparations.
4. Received local-regional therapy within 4 weeks before the first dose of the study drug, including but not limited to surgery, radiotherapy, hepatic artery embolism, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection.
5. History of other malignant tumors within 5 years prior to screening, except for hepatocellular carcinoma.
6. Presence of unhealed severe wounds, active ulcers, or untreated fractures.
7. Active autoimmune disease or history of autoimmune disorders.
8. Significant history of gastrointestinal diseases.
9. Significant history of cardiovascular or cerebrovascular diseases.

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Shi Feng

Conditions HCC - Hepatocellular Carcinoma