HAIC Combined with PD-1 Inhibitor in Potentially Resectable Locally Advanced HCC

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 25, 2019

Primary Completion Date

July 20, 2020

Study Completion Date

December 31, 2025

Conditions
Hepatocellular Carcinoma
Interventions
COMBINATION_PRODUCT

HAIC+PD1

Sintilimab ( 200mg Q3W iv D1)+FOLFOX-HAIC(oxaliplatin, 130 mg/m2 and leucovorin, 200 mg/m2, and fluorouracil, 400 mg/m2, bolus and 2400 mg/m2 over 46 hours Q3W D2 D3), maximally 8 cycles Multi-disciplinary consultation was organized to decide the chance of surgery and subsequent treatment per 2 treatment cycles. Patients who achieved partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and were assessed as eligible for R0 resection go on to undergo surgical resection. After recovery from operation , sintilimab monotherapy was given per three weeks for maximally 16 doses. Patients who were ineligible for resection would continue to receive the combination therapy.

DRUG

HAIC

FOLFOX-HAIC: oxaliplatin, 130 mg/m2 and leucovorin, 200 mg/m2, and fluorouracil, 400 mg/m2, bolus and 2400 mg/m2 over 46 hours Q3W D2 D3, for maximally 8 cycles, and the safety parameters are reviewed before the start of each course of HAIC treatment. Patients who achieve partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and are assessed as eligible for R0 resection go on to undergo surgical resection. No other anti-tumor therapies are allowed before PD or postoperative relapse is confirmed.

Trial Locations (1)

510060

Sun Yat-sen University Cancer Center, Guangzhou

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Innovent Biologics, Inc.

OTHER

lead

Sun Yat-sen University

OTHER

NCT03869034 - HAIC Combined with PD-1 Inhibitor in Potentially Resectable Locally Advanced HCC | Biotech Hunter | Biotech Hunter