Surufatinib Combined With Toripalimab and HAIC in the Treatment of Inoperable or Metastatic Intrahepatic Cholangiocarcinoma

NCT06313554 NA NOT_YET_RECRUITING

This study is a single-arm, open-arm, single-center clinical study to explore the efficacy and safety of HAIC in combination with Surufatinib and Toripalimab in patients with inoperable or metastatic intrahepatic cholangiocarcinoma. The study was divided into three stages: screening period, treatment period and follow-up period. During the treatment period, the tumor status was evaluated by imaging every 6 weeks (±7 days), and the efficacy was changed to every 8 weeks (±7 days) after 12 weeks until the disease progressed (RECIST 1.1) or death (during the treatment of the patient) or toxicity became intolerable. The tumor treatment status and survival status after the disease progression were recorded. Safety outcome measures included AE, changes in laboratory test values, vital signs and electrocardiogram changes.

Details

Lead sponsor	Fudan University
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	63
Start date	Mon May 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu May 20 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

• Surufatinib、Toripalimab、Gemcitabine、Oxaliplatin