HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma
NCT06239532 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2024-11-21
Summary
This is a single center, single arm, phase II, prospective study to evaluate the safety and effectiveness of HAIC combined with TAE plus an ICI and an TKI in adult patients (aged ≥18 years) with unresectable intrahepatic cholangiocarcinoma.
Conditions
- Intrahepatic Cholangiocarcinoma
Interventions
- DRUG
-
HAIC+TAE
Procedure: HAIC+TAE After successful percutaneous hepatic artery cannulation for continuous pumping of drugs. Oxaliplatin(85 mg/m2); Raltitrexed (3 mg/m2) ,continuous infusion for 3 hours. HAIC was performed at an interval of at least 21 days.
- DRUG
-
Tislelizumab
Drug: Tislelizumab(200 mg) will be administered by IV infusion every 3 weeks
- DRUG
-
Surufatinib
Drug: Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time.
Sponsors & Collaborators
-
BeiGene
collaborator INDUSTRY -
Qilu Hospital of Shandong University
lead OTHER
Principal Investigators
-
Zongli Zhang · Qilu Hospital of Shandong University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-27
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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