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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Main Who May Qualify: - Signed written willing to sign a consent form - 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 - your organs (liver, kidneys, etc.) are working well enough based on blood tests Main Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body) - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (1)

Shanghai General Hospital
Shanghai, Shanghai Municipality, China