Clinical trial · Interventional
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
NCT06532617CI-TRIAL-00089683recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cadonilimab+S-1or Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cadonilimab+S-1or Capecitabine
- interventionNames
- Drug: Cadonilimab+S-1or Capecitabine
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- Up to 2 years
- description
- Defined as the proportion of patients with a complete response or partial response to treatment according to RECIST1.1
Secondary outcomes (4)
- measure
- Overall survival (OS)
- timeFrame
- Up to 2 years
- description
- Defined as the length of time from the first dose to death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.