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

Biliary Tract Neoplasms Clinical Trial

— Modified  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06037655
• Other study ID #: MA-BTC-II-002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 25, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Xiangcheng Li
• Phone: 18951999088
• Email: drlixc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression free survival (PFS)	PFS is defined as time interval from recruitment to tumor progression or censoring	2 years
Other	Pathological Complete Response Rate (pCR)	pathological complete response rate	18 weeks
Other	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
Primary	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	overall survival (OS)	Overall survival	2 years