Transarterial Infusion of PD-1 Antibody Plus TACE-HAIC for Unresectable HCC: a Single-arm, Phase 2 Clinical Trial
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Drug: PD-1 inhibitor
- Registration Number
- NCT04814030
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
Hepatocellular carcinoma (HCC) is a common disease in East Asia. Less than 20% of newly diagnosed patients can undergo radical resection. For those with unresectable BCLC C stage, transarterial chemotherapy and targeted therapy are recommend to prolong survival. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Transartery infusion of agents provide promising outcome when compared systemic infusion. Furthermore, our pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC plus hepatic artery infusion PD-1 antibody would improve survival for unresectalbe BCLC C stage patients is still unknown. A single arm, phase 2 clinical trial is aimed to answer this question.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- BCLC C stage with unresectable diseasehigh-recurrence risk factor;
- Child-Pugh A or B (7 score) liver function;
- Anticipated survival more than 3 moths
- Pregnant woman or sucking period;
- With other malignant cancer;
- Received anti-HCC therapy before this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AIPD-1 PD-1 inhibitor Trans hepatic artery infusion of PD-1 antibody, chemoembolization, FOLFOX-based infusion chemotherapy
- Primary Outcome Measures
Name Time Method overall response rate 12 month defined as the sum of complete responses (CRs) and partial responses (PRs) over a specified time period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China