NCT05493332

HAIC Combined With Donafenib Tosilate and Toripalimab for Unresectable HCC

A Prospective, Single-armed, Multicentric, Explorative Phase II Clinical Research of Conversional Therapy With Combination of Hepatic Arterial Infusion Chemotherapy and Donafenib and Toripalimab for Unresectable Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-armed, multicentric, explorative phase II clinical research of conversional therapy with combination of hepatic arterial infusion chemotherapy(HAIC), Donafenib Tosilate and Toripalimab for unresectable hepatocellular carcinoma.

Detailed description

Compared with systemic intravenous chemotherapy, hepatic arterial infusion chemotherapy(HAIC) has the advantages of increasing local drug concentration and reducing systemic toxic and side effects. Currently, it is gradually used in the treatment of hepatocellular carcinoma (HCC) with good safety and high objective response rate. Immunotherapy combined with targeted and chemotherapy was well tolerated. At present, anti-programmed cell death protein-1(PD-1) antibody combined with chemotherapy and targeted therapy for advanced biliary tract tumors has initially shown good safety and encouraging efficacy, which is worthy of further exploration. Therefore, this study aims to evaluate the efficacy and safety of HAIC (FOLFOX) combined with Toripalimab and Donafenib Tosilate in unresectable HCC.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	HAIC(FOLFOX)	After successful percutaneous hepatic artery cannulation, superior mesenteric arteriogram and hepatic arteriogram were performed, and after confirming that the subjects were eligible for enrollment according to the results, the hepatic artery was cannulated to the predetermined position. The catheter was connected to a syringe pump in the ward for continuous pumping of chemotherapy drugs.
DRUG	Oxaliplatin	85mg/m2 IVdrip from hour 0 to 2 on D1，Q3W
DRUG	Leucovorin	400mg/m2 IVdrip , from hour 0 to 2 on D1 to D2，Q3W
DRUG	Fluorouracil	400mg/m2 , bolus at hour 3 ; and 600mg/m2 IVdrip over 46 hours on D1 to D2，Q3W
DRUG	Toripalimab	240mg IVdrip，D3, Q3W
DRUG	Donafenib	0.1g. P.O, BID, continuously

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2022-08-09
• Last updated: 2022-08-18