Adebrelimab Combined With Chemotherapy for Neoadjuvant Therapy in Resectable Pancreatic Cancer

Phase 2

Recruiting

• Conditions: Pancreatic Cancer; Neoadjuvant Therapy
• Interventions: Drug: Adebrelimab; Drug: albumin-bound paclitaxel; Drug: Gemcitabine

• Registration Number: NCT06177522
• Lead Sponsor: Jinling Hospital, China

Brief Summary

Clinical Study on the Safety and Efficacy of the efficacy and safety of Adebrelimab combined with chemotherapy for neoadjuvant treatment of resectable pancreatic cancer

Detailed Description

The goal of this clinical trial is to observe and evaluate the efficacy and safety of Adebrelimab combined with chemotherapy for neoadjuvant treatment of resectable pancreatic cancer.The main questions it aims to answer are:

To investigate the feasibility of immunotherapy combined with chemotherapy in the neoadjuvant therapy of pancreatic cancer.

To explore more effective neoadjuvant therapies for pancreatic cancer. Participants will receive 2 cycles of Adebrelimab in combination with albumin-bound paclitaxel and gemcitabine in the neoadjuvant phase, followed by surgery.

Study Timeline

• Study Start: 2023-12-06
• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-11
• Study First Posted: 2023-12-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16
• Primary Completion: 2024-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adebrelimab combined with chemotherapy administration group	albumin-bound paclitaxel	Adebrelimab is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Pharmaceutical. It can block the PD-1/PD-L1 pathway leading to tumor immune tolerance through specific binding of PD-L1 molecules, and reactivate the anti-tumor activity of the immune system, so as to achieve the purpose of tumor treatment.
Adebrelimab combined with chemotherapy administration group	Gemcitabine	Adebrelimab is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Pharmaceutical. It can block the PD-1/PD-L1 pathway leading to tumor immune tolerance through specific binding of PD-L1 molecules, and reactivate the anti-tumor activity of the immune system, so as to achieve the purpose of tumor treatment.
Adebrelimab combined with chemotherapy administration group	Adebrelimab	Adebrelimab is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Pharmaceutical. It can block the PD-1/PD-L1 pathway leading to tumor immune tolerance through specific binding of PD-L1 molecules, and reactivate the anti-tumor activity of the immune system, so as to achieve the purpose of tumor treatment.

Primary Outcome Measures

Name	Time	Method
R0 removal rate	one year	To observe and evaluate the efficacy and safety of adbelizumab combined with chemotherapy for neoadjuvant treatment of resectable pancreatic cancer
pCR rate	one year	To observe and evaluate the efficacy and safety of adbelizumab combined with chemotherapy for neoadjuvant treatment of resectable pancreatic cancer

Trial Locations

Locations (1)

Wang Sizhen; 🇨🇳 Nanjing, Jiangsu, China