NCT06532617 Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer
| NCT ID | NCT06532617 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
| Condition | Pancreatic Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-09-19 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-09-19 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 advanced pancreatic cancer.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT06532617 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pancreatic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06532617 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06532617 currently recruiting?
Yes, NCT06532617 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine to inquire about joining.
Where is the NCT06532617 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06532617 clinical trial?
NCT06532617 is sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 30 participants.