NCT06313554

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

A Single-center, Single-arm, Open-label Clinical Study of Surufatinib Combined With Toripalimab and HAIC in Patients With Inoperable or Metastatic Intrahepatic Cholangiocarcinoma

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Surufatinib、Toripalimab、Gemcitabine、Oxaliplatin	The first week dose of Surufatinib was 150mg, the second week and the subsequent cycle was 200 mg once a day (QD) orally, Q3W, and the drug was suspended for one day on the day of HAIC; Toripalimab: 240mg intravenous infusion d1, Q3W; HAIC: All patients received HAIC treatment on D1. Hepatic arterial perfusion therapy (HAIC) : a treatment cycle every 3 weeks for 4-6 consecutive cycles: Surufatinib and Toripalimab were administered continuously until intolerable toxicity, disease progression, withdrawal of informed consent, loss of follow-up, and investigator judgment that medication should be discontinued (whichever occurred first).

Timeline

• Start date: 2024-05-20
• Primary completion: 2024-05-20
• Completion: 2027-05-20
• First posted: 2024-03-15
• Last updated: 2024-03-15