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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-19

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HCC - Hepatocellular Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immune checkpoint inhibitors combined with anti-VEGF drugs

Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.

Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib.

Group Type ACTIVE_COMPARATOR

Lenvatinib

Intervention Type DRUG

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

Pembrolizumab

Intervention Type DRUG

200 mg intravenously every three weeks

Atezolizumab

Intervention Type DRUG

1200 mg intravenously every three weeks

Bevacizumab

Intervention Type DRUG

15mg/kg intravenously every three weeks

Camrelizumab

Intervention Type DRUG

200 mg intravenously every three weeks

Apatinib

Intervention Type DRUG

250mg once daily

Tislelizumab

Intervention Type DRUG

200 mg intravenously every three weeks

Sintilimab

Intervention Type DRUG

200 mg intravenously every three weeks

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

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.

Group Type EXPERIMENTAL

Lenvatinib

Intervention Type DRUG

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

Pembrolizumab

Intervention Type DRUG

200 mg intravenously every three weeks

Atezolizumab

Intervention Type DRUG

1200 mg intravenously every three weeks

Bevacizumab

Intervention Type DRUG

15mg/kg intravenously every three weeks

Camrelizumab

Intervention Type DRUG

200 mg intravenously every three weeks

Apatinib

Intervention Type DRUG

250mg once daily

TACE

Intervention Type PROCEDURE

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

HAIC

Intervention Type PROCEDURE

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

DEB-TACE

Intervention Type PROCEDURE

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

Tislelizumab

Intervention Type DRUG

200 mg intravenously every three weeks

Sintilimab

Intervention Type DRUG

200 mg intravenously every three weeks

Interventions

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Lenvatinib

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

Intervention Type DRUG

Pembrolizumab

200 mg intravenously every three weeks

Intervention Type DRUG

Atezolizumab

1200 mg intravenously every three weeks

Intervention Type DRUG

Bevacizumab

15mg/kg intravenously every three weeks

Intervention Type DRUG

Camrelizumab

200 mg intravenously every three weeks

Intervention Type DRUG

Apatinib

250mg once daily

Intervention Type DRUG

TACE

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

Intervention Type PROCEDURE

HAIC

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

Intervention Type PROCEDURE

DEB-TACE

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

Intervention Type PROCEDURE

Tislelizumab

200 mg intravenously every three weeks

Intervention Type DRUG

Sintilimab

200 mg intravenously every three weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No