Status:
NOT_YET_RECRUITING
Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Biliary Tract Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
After being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06037655
Start Date
September 25 2023
End Date
December 31 2026
Last Update
September 14 2023
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