Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer

May 13, 2025 updated by: Jiang Long, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

A Single-arm Phase II Clinical Study of Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Patients With Advanced Pancreatic Cancer

This is a single arm, single cencer, phase II clinical trial. This study aims to evaluate the efficacy and safety of Cadonilimab combined with S-1 or capecitabine as a second-line treatment for advanced pancreatic cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Shanghai General Hospital
        • Contact:
        • Principal Investigator:
          • Jiang Long, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  • Signed written informed consent
  • Age 18-80, female or male
  • Histopathologically confirmed pancreatic ductal adenocarcinoma
  • Patients with locally advanced pancreatic cancer who have previously received standard first-line anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.)
  • Locally advanced pancreatic cancer is defined as follows: a. The tumor has no distant metastasis; b. Pancreatic head/uncinate process: The tumor contacts the superior mesenteric artery >180˚; c. Pancreatic body and tail: The tumor contacts the superior mesenteric artery or celiac artery >180˚; The tumor contacts the celiac artery and infiltrates the abdominal aorta; d. The tumor invades the jejunal branch of the superior mesenteric artery. Portal vein-superior mesenteric vein cannot be safely reconstructed due to tumor invasion, vein occlusion, or involvement of a large range of jejunal branches of the superior mesenteric vein.
  • At least one measurable lesion (RECIST1.1)
  • ECOG PS 0-1
  • Expected survival time>3 months
  • Adequate organ function

Main Exclusion Criteria:

  • Malignant diseases other than pancreatic cancer diagnosed within 5 years before the first dose (excluding radically resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ)
  • Currently participating in interventional clinical research treatment, or having received other research drugs or used research devices within 4 weeks before the first dose
  • Active autoimmune disease
  • Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Allergic to the active ingredients or excipients of this study drug, cadonilimab, S-1 or capecitabine
  • Have not fully recovered from any toxicity and/or complications caused by the intervention before starting treatment
  • History of HIV
  • Active HBV or HCV
  • Pregnant or breastfeeding women
  • Any severe or uncontrolled systemic disease
  • Active pulmonary tuberculosis
  • People with mental disorders who are unable to cooperate with treatment
  • Uncontrolled infection
  • The investigators assess that the subjects are unable to complete the entire trial process or are otherwise unsuitable for participating in this trial

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cadonilimab+S-1or Capecitabine
Drug: Cadonilimab+S-1or Capecitabine
Eligible patients will receive Cadonilimab (6mg/k, iv, D1,Q3W)combined with S-1 (40-60mg po BID Q3W D1-14）or Capecitabine (1250mg/m2, po BID Q3W D1-14）until disease progression or unacceptable toxicity. Patients who had used S-1 in the first line should choose capecitabine; patients who had used capecitabine in the first line should choose S-1; otherwise decided by investigator's choice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Up to 2 years
Defined as the proportion of patients with a complete response or partial response to treatment according to RECIST1.1
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 2 years
Defined as the length of time from the first dose to death from any cause.
Up to 2 years
Progression-free survival (PFS)
Time Frame: Up to 2 years
Defined as the length of time from the first dose to progression disease or death from any cause.
Up to 2 years
Disease control rate (DCR)
Time Frame: Up to 2 years
Defined as the proportion of patients with a complete response, partial response or stable disease to treatment according to RECIST1.1
Up to 2 years
Duration of response (DoR)
Time Frame: Up to 2 years
Defined as the length of time from first tumor response (CR or PR) to disease progression (PD) or death.
Up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker analysis
Time Frame: Up to 2 years
Biomarkers that potentially predict efficacy include, but are not limited to, PD-L1 expression and T cell subpopulations in tumor tissue specimens or blood samples and so on.
Up to 2 years

Collaborators and Investigators

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

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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 Major Dates

Study Start (Actual)

September 19, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240515024702669

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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