Trials / Not Yet Recruiting
Not Yet RecruitingNCT07109167
The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- The Second Affiliated Hospital of Shandong First Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the progression-free survival (PFS) of benmelstobart combined with gemcitabine and cisplatin in first-line patients with advanced cholangiocarcinoma, and the progression-free survival (PFS) of benmelstobart combined with anlotinib in second-line patients with advanced cholangiocarcinoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Benmelstobart combined with gemcitabine and cisplatin | Benmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8;Cisplatin 25mg/m², intravenous infusion on Day 1 and Day 8. Maintenance dose of study medication: Benmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8 |
Timeline
- Start date
- 2025-08-01
- Primary completion
- 2026-08-01
- Completion
- 2027-08-01
- First posted
- 2025-08-07
- Last updated
- 2025-08-07
Source: ClinicalTrials.gov record NCT07109167. Inclusion in this directory is not an endorsement.