PD-1 Inhibitors Combined With Targeted Therapy With or Without Interventional Therapy for Advanced HCC
Not Applicable
Recruiting
- Conditions
- HCC - Hepatocellular Carcinoma
- Interventions
- Procedure: TACEProcedure: HAICProcedure: DEB-TACE
- Registration Number
- NCT07157969
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
This trial is designed to explore the efficacy and safety of interventional therapy combined with PD-1 inhibitors and targeted therapy in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving PD-1 inhibitors combined with targeted therapy, and the other receiving PD-1 inhibitors combined with targeted therapy 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 (ORR), while secondary endpoints include Disease Control Rate (DCR), Progression-Free Survival (PFS), Overall Survival (OS), Duration of Response (DoR), Adverse Events (AE), and Serious Adverse Events (SAE).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PD-1 inhibitors combined with targeted therapy Lenvatinib - PD-1 inhibitors combined with targeted therapy Pembrolizumab - PD-1 inhibitors combined with targeted therapy Atezolizumab - PD-1 inhibitors combined with targeted therapy Bevacizumab - PD-1 inhibitors combined with targeted therapy Camrelizumab - PD-1 inhibitors combined with targeted therapy alongside interventional therapy Lenvatinib Interventional therapy includes C-TACE, D-TACE, and HAIC PD-1 inhibitors combined with targeted therapy Apatinib - PD-1 inhibitors combined with targeted therapy alongside interventional therapy Camrelizumab Interventional therapy includes C-TACE, D-TACE, and HAIC PD-1 inhibitors combined with targeted therapy alongside interventional therapy Apatinib Interventional therapy includes C-TACE, D-TACE, and HAIC PD-1 inhibitors combined with targeted therapy alongside interventional therapy HAIC Interventional therapy includes C-TACE, D-TACE, and HAIC PD-1 inhibitors combined with targeted therapy alongside interventional therapy Pembrolizumab Interventional therapy includes C-TACE, D-TACE, and HAIC PD-1 inhibitors combined with targeted therapy alongside interventional therapy Bevacizumab Interventional therapy includes C-TACE, D-TACE, and HAIC PD-1 inhibitors combined with targeted therapy alongside interventional therapy Atezolizumab Interventional therapy includes C-TACE, D-TACE, and HAIC PD-1 inhibitors combined with targeted therapy alongside interventional therapy TACE Interventional therapy includes C-TACE, D-TACE, and HAIC PD-1 inhibitors combined with targeted therapy alongside interventional therapy DEB-TACE Interventional therapy includes C-TACE, D-TACE, and HAIC
- Primary Outcome Measures
Name Time Method ORR, objective response rate 12 months after the last subject is enrolled
- Secondary Outcome Measures
Name Time Method DCR, disease control rate 12 months after the last subject is enrolled PFS, progression free survival 12 months after the last subject is enrolled Serious adverse events (SAE) 12 months after the last subject is enrolled OS, overall survival 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
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, China
Peking Union Medical College Hospital🇨🇳Beijing, ChinaHaitao ZhaoContact+86-10-69152830zhaoht@pumch.cn