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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Biliary Tract Neoplasms
• Intervention / Treatment: Drug: Total Neoadjuvant Treatment

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiangcheng Li; Phone Number: 18951999088; Email: drlixc@163.com
• Study Contact Backup: Name: Xiaofeng Chen; Phone Number: 13585172066

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)	Overall survival	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	PFS is defined as time interval from recruitment to tumor progression or censoring	2 years
Pathological Complete Response Rate (pCR)	pathological complete response rate	18 weeks
Major Pathological Response Rate (MPR)	MPR rate was defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%)	18 weeks

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Estimated): September 25, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: MA-BTC-II-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No