NCT06892925

QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: Eastern Hepatobiliary Surgery Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This open - label, prospective, single - arm, multicenter phase II clinical study aims to assess the efficacy and safety of QL1706 combined with lenvatinib and GEMOX as first - line treatment for patients with unresectable biliary tract tumors.

Conditions

• Biliary Tract Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-14
• Primary completion: 2026-04-01
• Completion: 2029-04-01
• First posted: 2025-03-25
• Last updated: 2025-07-10

Locations

1 site across 1 country: China