NCT06591520

AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer

A Randomized, Controlled, Multi-center Phase III Study of AK112 Combined With Gemcitabine Plus Cisplatin Versus Durvalumab Combined With Gemcitabine Plus Cisplatin as the First-line Treatment for Patients With Advanced Biliary Tract Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 682 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3 study. All subjects are patients with unresectable locally advanced or metastatic biliary tract cancer (BTC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy versus durvalumab in combination with chemotherapy in patients with unresectable locally advanced or metastatic BTC.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	AK112, Gemcitabine, Cisplatin	AK112 will be administered at a selected dose intravenously (IV) every three weeks (Q3W). Gemcitabine will be administered at 1000 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles. Cisplatin will be administered at 25 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles.
DRUG	Durvalumab, Gemcitabine, Cisplatin	Durvalumab will be administered at 1500mg intravenously (IV) every three weeks (Q3W) for 8 cycles and followed by monotherapy every 4 weeks. Gemcitabine will be administered at 1000 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles. Cisplatin will be administered at 25 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles.

Timeline

• Start date: 2024-10-20
• Primary completion: 2026-10-01
• Completion: 2027-12-01
• First posted: 2024-09-19
• Last updated: 2026-01-21

Locations

2 sites across 1 country: China