Clinical trial · Interventional
Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC
Gemcitabine/Cisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study
NCT06037655CI-TRIAL-00069624Modifiednot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Total Neoadjuvant Treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation
- interventionNames
- Drug: Total Neoadjuvant Treatment
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 18 weeks
- description
- ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1
Secondary outcomes (1)
- measure
- overall survival (OS)
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female * Age ≥ 18 years，≤ 75 years * Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are difficult to directly resecte surgically * Ability to provide written informed consent prior to participation in any study-related procedure * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * At least one, not previously irradiated, measurable lesion according to RECIST (version 1.1). * Adequate organ function Exclusion Criteria: * Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma * Known history of a serious allergy to any monoclonal antibody * Any active malignancy prior to the start of treatment * Active or history of autoimmune disease * Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.