Status:
RECRUITING
Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 advanc...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
September 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06532617
Start Date
September 19 2024
End Date
August 1 2027
Last Update
May 14 2025
Active Locations (1)
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1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200040