Adebrelimab Combined With AG Regimen In Patients With Unresectable Locally Advanced Or Metastatic Pancreatic Cancer

Study Overview

Adebrelimab Combined With AG Regimen in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

This study aims to evaluate the efficacy and safety of adebrelimab combined with the AG regimen in patients with unresectable locally advanced or metastatic pancreatic cancer who have received at least one prior line of systemic therapy but have not undergone gemcitabine-based treatment.

N/A

Pancreatic Cancer Non-resectable
Pancreatic Cancer Metastatic

DRUG: Adebrelimab
DRUG: AG

CSPAC-48

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-04-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-01
First Submitted that Met QC Criteria 2025-04-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-08
First Posted (ACTUAL) 2025-04-08	Results First Posted N/A	Last Verified 2025-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm Adebrelimab combined with the AG	DRUG: Adebrelimab Adebrelimab: 1200mg，iv，d1，q3w； DRUG: AG Gemcitabine: 1000 mg/m² ，iv，d1、d8，q3w； Nab-paclitaxel: 125 mg/m² ，iv，d1、d8，q3w；

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm

Adebrelimab combined with the AG

DRUG: Adebrelimab

Adebrelimab: 1200mg，iv，d1，q3w；

DRUG: AG

Gemcitabine: 1000 mg/m² ，iv，d1、d8，q3w； Nab-paclitaxel: 125 mg/m² ，iv，d1、d8，q3w；

Primary Outcome Measures	Measure Description	Time Frame
ORR	Objective response rate	up to 20 weeks

Secondary Outcome Measures	Measure Description	Time Frame
PFS	Progression-free survival	up to 20 weeks
OS	Overall survival	1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Safety will be evaluated according to the NCI CTCAE Version 5.0. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.	through study completion, an average of 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jin Xu

Phone Number: 18017317267

Email: xujin@fudanpci.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Sign informed consent；
Aged 18-75 years (inclusive)；
Histologically or cytologically confirmed pancreatic cancer；
Unresectable locally advanced or metastatic pancreatic cancer, as determined by the investigator；
Disease progression after prior treatment with at least one systemic therapy;
No previous immunotherapy;
No previous gemcitabine-based chemotherapy;
Have at least one measurable lesion (according to RECIST 1.1 criteria);
ECOG 0~1；
The estimated survival time is greater than 3 months;
Adequate Organ Function (within 28 days prior to first dose): Hematology: White blood cell count (WBC) ≥3.0×10⁹/L Absolute neutrophil count (ANC) ≥1.5×10⁹/L Platelets (PLT) ≥100×10⁹/L Hemoglobin (HGB) ≥90 g/L Liver Function: Aspartate aminotransferase (AST) ≤2.5×ULN Alanine aminotransferase (ALT) ≤2.5×ULN Total bilirubin (TBIL) ≤1.5×ULN Renal Function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CrCl) ≥60 mL/min (calculated via Cockcroft-Gault formula). Coagulation: International normalized ratio (INR) ≤1.5 Activated partial thromboplastin time (APTT) ≤1.5×ULN Cardiac Function: No clinically significant abnormalities on electrocardiogram (ECG)；
Male subjects and females of childbearing potential must agree to use effective contraceptive measures from the first dose until 3 months after the last dose of the study drug.

The subject has any known active autoimmune disease;
Subjects have any complications requiring systemic treatment with corticosteroids such as prednisone (> 10mg/ day) or have used immunosuppressive drugs within 14 days prior to initial administration;
Subjects received tumor vaccines or other immune-activating antitumor drugs (such as interferon, interleukin, thymosin, or immune cell therapy) within 1 month prior to initial administration;
Subjects are participating in another clinical trial or have received a drug intervention from another clinical trial within 4 weeks prior to the first dose;
Subjects have other malignancies requiring treatment;
Clinically significant cardiovascular disorders；
Prior allogeneic organ transplantation or hematopoietic stem cell transplantation；
Serologically confirmed HIV infection；
Active hepatitis B (HBsAg-positive with HBV-DNA ≥10³ copies/mL). Active hepatitis C (HCV antibody-positive with detectable HCV RNA and requiring antiviral therapy)；
Known hypersensitivity to monoclonal antibodies or any component of adebrelimab；
History of severe allergic reactions to gemcitabine or nab-paclitaxel；
Any situation that the investigator believes may compromise the validity of the trial or patient safety.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record