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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.

HAIC(FOLFOX)

85mg/m2 IVdrip from hour 0 to 2 on D1，Q3W

400mg/m2 IVdrip , from hour 0 to 2 on D1 to D2，Q3W

400mg/m2 , bolus at hour 3 ; and 600mg/m2 IVdrip over 46 hours on D1 to D2，Q3W

Toripalimab

Donafenib

Yongcong Yan

Zhiyu Xiao

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.

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.

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

Defined as the proportion of patients who met the resection criteria after conversion therapy and successfully underwent radical resection surgery to the total number of patients enrolled.

Defined as the proportion of patients who met the resection criteria based on imageological proof after conversion therapy to the total number of patients enrolled.

Defined as proportion of patients who have a best response of treatment.

Defined as the proportion of cases with remission and stable lesions after treatment was assessable.

Defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression).

Defined as time from the start of treatment until death due to any reason.

Defined as the time from date of randomization until the date of recurrence.

Defined as the time from date of randomization until the date of patients who met a reasonable response to treatment.

Safety as measured by number and grade of adverse events

Any potential types of measurement self-reported by the patients.

Spots Global Cancer Trial Database for haic(folfox)

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