Trials / Unknown
UnknownNCT06134193
Combination Therapy of HAIC, Surufatinib and Tislelizumab for Unresectable or Metastatic Biliary Tract Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (estimated)
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-arm, exploratory study to evaluate the efficacy and safety of HAIC in combination with surufatinib and tislelizumab in the first line treatment of patients with unresectable or metastatic biliary tract cancer
Conditions
- Carcinoma
- Intrahepatic Cholangiocarcinoma
- Gallbladder Cancer
- Surufatinib
- Angiogenesis Inhibitors
- Tislelizumab
- Antineoplastic Agents, Immunological
- Immunotherapy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HAIC | hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil, leucovorin (FOLFOX) treatment (Q3W) Oxaliplatin: 85mg/m2 , Day 1 Leucovorin: 200mg/m2, Day 1 Fluorouracil: 400mg/m2, Day1 and 2400mg/m2 continuous arterial perfusion for 46h. |
| DRUG | Surufatinib | 250mg PO d1, Q3W |
| DRUG | Tislelizumab | 200mg IV d1, Q3W |
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2024-06-01
- Completion
- 2025-06-01
- First posted
- 2023-11-18
- Last updated
- 2023-11-18
Source: ClinicalTrials.gov record NCT06134193. Inclusion in this directory is not an endorsement.