ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC

NCT07157969 · tracked via the Priya Life Science China tracker

Sponsor

Peking Union Medical College Hospital

Phase

Phase 2

Started

2025-02-19

Last updated

2025-12-01

Condition(s) studied

HCC - Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

Lenvatinib →Pembrolizumab →Atezolizumab →Bevacizumab →Camrelizumab →Apatinib →TACEHAICDEB-TACETislelizumab →Sintilimab →

Lenvatinib: ≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily

Pembrolizumab: 200 mg intravenously every three weeks

Atezolizumab: 1200 mg intravenously every three weeks

Bevacizumab: 15mg/kg intravenously every three weeks

Camrelizumab: 200 mg intravenously every three weeks

Apatinib: 250mg once daily

TACE: The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.

HAIC: The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.

DEB-TACE: The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.

Tislelizumab: 200 mg intravenously every three weeks

Sintilimab: 200 mg intravenously every three weeks

Study summary

This trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving ICIs combined with anti-VEGF drugs, and the other receiving ICIs combined with anti-VEGF drugs alongside interventional therapy, which includes C-TACE, D-TACE, and HAIC. The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.

Researchers will closely monitor and rigorously evaluate the efficacy and safety of the treatment in participants through follow-up assessments. The primary endpoint is the objective response rate , while secondary endpoints include disease control rate, progression-free survival, overall survival, duration of response, adverse events, and serious adverse events.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

ORR, objective response rate — 12 months after the last subject is enrolled

Trial sites (1)

Facility	City	Region	Status
Peking Union Medical College Hospital	Beijing	China	Recruiting

On this site

📄 Lenvima (lenvatinib) drug profile → 📄 Keytruda (pembrolizumab) drug profile → 📄 Tecentriq (atezolizumab) drug profile → 📄 Avastin (bevacizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07157969 on ClinicalTrials.gov ↗ ← All trials in China