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NCT07109167
The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors
Phase 2 trial testing Benmelstobart combined with gemcitabine and cisplatin in Biliary Tract Neoplasms in 30 participants. Not yet recruiting.
1 August 2026
Quick facts
| Lead sponsor | The Second Affiliated Hospital of Shandong First Medical University |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 August 2025 |
| Primary completion | 1 August 2026 |
| Estimated completion | 1 August 2027 |
Drugs / interventions tested
- Benmelstobart combined with gemcitabine and cisplatin — full drug profile →
Conditions studied
- Biliary Tract Neoplasms — all drugs for Biliary Tract Neoplasms →
Sponsor
The Second Affiliated Hospital of Shandong First Medical University
Who can join
Adults 18 to 75, any sex, with Biliary Tract Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07109167
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Biliary Tract Neoplasms
Currently open trials in the same condition.
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- NCT04579380 — Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations · Phase 2 · active not recruiting
- NCT04308174 — Neoadjuvant Gemcitabine Plus Cisplatin With or Without Durvalumab in Resectable Biliary Tract Cancer · Phase 2 · active not recruiting
- NCT03875235 — Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer · Phase 3 · active not recruiting
- NCT03801083 — Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers · Phase 2 · recruiting
Other The Second Affiliated Hospital of Shandong First Medical University trials
Trials by the same sponsor.
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- NCT05754736 — Clinical Study of Ametinib Combined With Bevacizumab in First-line Treatment of Advanced NSCLC With EGFR-mutations. · Phase 2 · unknown
- NCT05170594 — A Study of Bevacizumab Combined With Fluzoparib/Chemotherapy or Fluzoparib in the Treatment of Ovarian Cancer · Phase 2 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07109167 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Second Affiliated Hospital of Shandong First Medical University
- Last refreshed: 7 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07109167.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing