QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors
NCT06892925 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2025-07-10
Summary
QL1706 Combined with Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors:A Single - Arm, Open - Label, Multi - Center, Prospective Phase II Clinical Trial (Spring Study)
Conditions
- Biliary Tract Tumors
Interventions
- DRUG
-
QL1706
Eligible participants will receive QL1706 at 5.0 mg/kg intravenously every 3 weeks, lenvatinib at 8 mg orally once daily every 3 weeks, oxaliplatin at 85 mg/m², and gemcitabine at 1000 mg/m² (on days 1 and 8 of each cycle) for up to 8 cycles. Then, they will continue with QL1706 and lenvatinib until clinical progression, imaging progression per RECIST 1.1, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met.
Sponsors & Collaborators
-
Eastern Hepatobiliary Surgery Hospital
lead OTHER
Principal Investigators
-
Feng Shen · Eastern Hepatobiliary Surgery Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-14
- Primary Completion
- 2026-04-30
- Completion
- 2029-04-30
Countries
- China
Study Locations
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