Biliary Tract Neoplasms
Conditions
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 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
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
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 18 weeks | ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | 2 years | Overall survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 2 years | PFS is defined as time interval from recruitment to tumor progression or censoring |
| Pathological Complete Response Rate (pCR) | 18 weeks | pathological complete response rate |
| Major Pathological Response Rate (MPR) | 18 weeks | MPR rate was defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%) |
Contacts
Primary ContactXiangcheng Li
Backup ContactXiaofeng Chen
Outcome results
None listed