Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC
Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Sep 7, 2023
Trial Information
Current as of July 25, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment combination for patients with a specific type of cancer called biliary tract cancer (BTC), which affects the bile ducts and gallbladder. The researchers want to see if giving chemotherapy along with two new drugs, Adebrelimab and Mecapegfilgrastim, before surgery can help shrink the tumors and make them easier to remove. This study is not yet recruiting participants, but when it starts, it will involve adults aged 18 to 75 who have locally advanced BTC that can still be surgically treated.
To participate, individuals must have measurable cancer that hasn’t been treated yet and be in good overall health, with no serious allergies to similar medications or other active cancers. Participants will receive the combination treatment and be closely monitored for safety and effectiveness. If you or a loved one are considering this trial, it’s important to discuss it with your doctor to see if it may be a good option for you.
Gender
ALL
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
About The First Affiliated Hospital With Nanjing Medical University
The First Affiliated Hospital of Nanjing Medical University is a leading medical institution dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital is committed to implementing rigorous scientific methodologies to evaluate new therapies and treatment approaches. With a multidisciplinary team of experienced healthcare professionals and researchers, the hospital fosters a collaborative environment aimed at enhancing patient outcomes and contributing to the global medical community. Its strategic focus on translational medicine ensures that groundbreaking discoveries are efficiently translated into practical applications for patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Xiangcheng Li
Study Chair
The First Affiliated Hospital with Nanjing Medical University
Xiaofeng Chen
Principal Investigator
The First Affiliated Hospital with Nanjing Medical University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported