Cadonilimab with S-1 or Capecitabine for advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of Cadonilimab, a PD-1/CTLA-4 bispecific antibody, when combined with either S-1 or capecitabine as a second-line treatment for patients with advanced pancreatic cancer. It is a single-arm, single-center phase II trial, focusing on patients who have previously undergone standard first-line treatments. The study aims to determine how well this combination therapy works in managing locally advanced pancreatic ductal adenocarcinoma.

Why it matters

Who can join: the full rules

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

Where it's running

• Shanghai General Hospital
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.