Adebrelimab Combined With AG Regimen in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer (CSPAC-48)

A Prospective, Single-Arm, Phase II Clinical Trial of 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer Metastatic; Pancreatic Cancer Non-resectable
• Intervention / Treatment: Drug: Adebrelimab; Drug: AG

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jin Xu; Phone Number: 18017317267; Email: xujin@fudanpci.org

Study Locations

• China
  • ShangHai, China
    • Fudan University Shanghai Cancer Center
    • Contact: Jin Xu; Phone Number: 180 1731 7267; Email: xujin@fudanpci.org

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

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: 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；

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival	1 year
PFS	Progression-free survival	up to 20 weeks
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

Collaborators and Investigators

• Sponsor: Jin Xu

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Estimated): April 8, 2025

Study Record Updates

• Last Update Posted (Estimated): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: pancreatic cancer
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: CSPAC-48

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
• product manufactured in and exported from the U.S.: No