Immunotherapy plus anti‑VEGF drugs with or without TACE/HAIC 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 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.

Why it matters

Who can join: the full rules

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 it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Shi Feng
• Email: fengshi0762@163.com
• Phone: 86-18601989848

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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.