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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Shi Feng
fengshi0762@163.com
86-18601989848
Time Frame
Start Date: 2025-02-19
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 300
Treatments
Active_comparator: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov

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