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

NCT07157969 | Recruiting Phase 2

• 1 other identifier: K7470
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HCC - Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR, objective response rate

  12 months after the last subject is enrolled

Secondary Outcomes (6)

• PFS, progression free survival

  12 months after the last subject is enrolled

• OS, overall survival

  12 months after the last subject is enrolled

• DCR, disease control rate

  12 months after the last subject is enrolled

• DoR, duration of response

  12 months after the last subject is enrolled

• Adverse events (AE)

  12 months after the last subject is enrolled

Study Arms (2)

Immune checkpoint inhibitors combined with anti-VEGF drugs

ACTIVE COMPARATOR

Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab. Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib.

Drug: Lenvatinib; Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Bevacizumab; Drug: Camrelizumab; Drug: Apatinib; Drug: Tislelizumab; Drug: Sintilimab

Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy

EXPERIMENTAL

Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab. Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC.

Drug: Lenvatinib; Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Bevacizumab; Drug: Camrelizumab; Drug: Apatinib; Procedure: TACE; Procedure: HAIC; Procedure: DEB-TACE; Drug: Tislelizumab; Drug: Sintilimab

Interventions

Lenvatinib DRUG

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

Immune checkpoint inhibitors combined with anti-VEGF drugs; Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy

Pembrolizumab DRUG

200 mg intravenously every three weeks

Immune checkpoint inhibitors combined with anti-VEGF drugs; Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy

Atezolizumab DRUG

1200 mg intravenously every three weeks

Immune checkpoint inhibitors combined with anti-VEGF drugs; Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy

Bevacizumab DRUG

15mg/kg intravenously every three weeks

Immune checkpoint inhibitors combined with anti-VEGF drugs; Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy

Camrelizumab DRUG

200 mg intravenously every three weeks

Immune checkpoint inhibitors combined with anti-VEGF drugs; Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy

Apatinib DRUG

250mg once daily

Immune checkpoint inhibitors combined with anti-VEGF drugs; Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy

TACE PROCEDURE

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

Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy

HAIC PROCEDURE

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

Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy

DEB-TACE PROCEDURE

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

Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy

Tislelizumab DRUG

200 mg intravenously every three weeks

Immune checkpoint inhibitors combined with anti-VEGF drugs; Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy

Sintilimab DRUG

200 mg intravenously every three weeks

Immune checkpoint inhibitors combined with anti-VEGF drugs; Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Pregnant or breastfeeding women.
• Individuals with known allergy or intolerance to recombinant humanized PD-1/PD-L1 monoclonal antibody preparations.
• 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.
• History of other malignant tumors within 5 years prior to screening, except for hepatocellular carcinoma.
• Presence of unhealed severe wounds, active ulcers, or untreated fractures.
• Active autoimmune disease or history of autoimmune disorders.
• Significant history of gastrointestinal diseases.
• Significant history of cardiovascular or cerebrovascular diseases.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related Publications (1)

• Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim JH, Zhao H, Li C, Madoff DC, Ghobrial RM, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry AB, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel AB, Finn RS, Llovet JM; LEAP-012 investigators. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. Lancet. 2025 Jan 18;405(10474):203-215. doi: 10.1016/S0140-6736(24)02575-3. Epub 2025 Jan 8.

  PMID: 39798578 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib; pembrolizumab; atezolizumab; Bevacizumab; camrelizumab; apatinib; tislelizumab; sintilimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Shi Feng

CONTACT

86-18601989848; fengshi0762@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: February 19, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)