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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cadonilimab+S-1or Capecitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadonilimab+S-1or Capecitabine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Defined as the proportion of patients with a complete response or partial response to treatment according to RECIST1.1 | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Defined as the length of time from the first dose to death from any cause. | Up to 2 years |
| Progression-free survival (PFS) | Defined as the length of time from the first dose to progression disease or death from any cause. |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker analysis | Biomarkers that potentially predict efficacy include, but are not limited to, PD-L1 expression and T cell subpopulations in tumor tissue specimens or blood samples and so on. | Up to 2 years |
Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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|
| Up to 2 years |
| Disease control rate (DCR) | Defined as the proportion of patients with a complete response, partial response or stable disease to treatment according to RECIST1.1 | Up to 2 years |
| Duration of response (DoR) | Defined as the length of time from first tumor response (CR or PR) to disease progression (PD) or death. | Up to 2 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |