Modified: Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06037655

Collaborator

(none)

Enrollment

Arm

39.2

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Neoplasms	Drug: Total Neoadjuvant Treatment	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Gemcitabine/Cisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study

Anticipated Study Start Date :

Sep 25, 2023

Anticipated Primary Completion Date :

Mar 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation	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

Arm

Intervention/Treatment

Experimental: Experimental

NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

overall survival (OS) [2 years]
Overall survival

Other Outcome Measures

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%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The First Affiliated Hospital with Nanjing Medical University

Investigators

Study Chair: Xiangcheng Li, The First Affiliated Hospital with Nanjing Medical University
Principal Investigator: Xiaofeng Chen, The First Affiliated Hospital with Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The First Affiliated Hospital with Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT06037655

Other Study ID Numbers:

MA-BTC-II-002

First Posted:

Sep 14, 2023

Last Update Posted:

Sep 14, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Biliary Tract Neoplasms

Study Results

No Results Posted as of Sep 14, 2023