RecruitingPhase 2NCT06532617

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

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


Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

30 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining cadonilimab (an immunotherapy drug) with an oral chemotherapy pill (S-1 or capecitabine) can help people with locally advanced pancreatic cancer that has not responded well to their first treatment. Pancreatic cancer is notoriously difficult to treat, and researchers are looking for new second-line options for patients who have already tried standard therapy. **You may be eligible if...** - You are 18 to 80 years old - You have confirmed pancreatic ductal adenocarcinoma (a specific type of pancreatic cancer) - Your cancer is locally advanced (not yet spread to distant organs) and has already been treated with at least one standard treatment - You have at least one measurable tumor on a scan - You are in reasonably good health (ECOG 0-1) with expected survival over 3 months - Your organ function is adequate **You may NOT be eligible if...** - You have another active cancer (other than certain skin cancers that have been treated) - You are currently in another clinical trial - You have active autoimmune disease - You have had an organ or stem cell transplant - You have a known allergy to cadonilimab, S-1, or capecitabine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCadonilimab+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.


Locations(1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

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NCT06532617


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