Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total Neoadjuvant Treatment.
- Who it may be relevant to
- Registry conditions: Biliary Tract Neoplasms. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Gemcitabine/Cisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study
Overview
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.
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 who meet the eligibility requirements will be receive Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim three weeks a cycle, surgery was performed after 4 cycles.
Interventions
- Drug Total Neoadjuvant Treatment
Adebrelimab (1200 mg) every three weeks intravenously; Mecapegfilgrastim (6 mg) every three weeks intravenously; Gemcitabine (1000 mg/m2) every three weeks on days 1 and 8 intravenously; Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously
Primary outcome measures
- Objective response rate (ORR) [Time frame: 18 weeks]
Secondary outcome measures (1)
- overall survival (OS) [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06037655 · MA-BTC-II-002