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RECRUITING

NCT06532617

PHASE2

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

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-09-19

Completion Date

2027-08-01

Last Updated

2025-05-14

Healthy Volunteers

Conditions

Pancreatic Neoplasms

Interventions

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.

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

Locations (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China