Transarterial Infusion of PD-1 Antibody Plus TACE-HAIC for Unresectable HCC: a Single-arm, Phase 2 Clinical Trial (AIPD-1)

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: PD-1 inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT04814030

B2021-060

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BCLC C stage with unresectable diseasehigh-recurrence risk factor;
• Child-Pugh A or B (7 score) liver function;
• Anticipated survival more than 3 moths

Exclusion criteria

• Pregnant woman or sucking period;
• With other malignant cancer;
• Received anti-HCC therapy before this study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

AIPD-1

Experimental group

Description:

Trans hepatic artery infusion of PD-1 antibody, chemoembolization, FOLFOX-based infusion chemotherapy

Treatment:

Drug: PD-1 inhibitor