Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer
- Registration Number
- NCT06532617
- Lead Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cadonilimab+S-1or Capecitabine Cadonilimab+S-1or Capecitabine -
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) Up to 2 years Defined as the proportion of patients with a complete response or partial response to treatment according to RECIST1.1
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Up to 2 years Defined as the length of time from the first dose to death from any cause.
Progression-free survival (PFS) Up to 2 years Defined as the length of time from the first dose to progression disease or death from any cause.
Duration of response (DoR) Up to 2 years Defined as the length of time from first tumor response (CR or PR) to disease progression (PD) or death.
Disease control rate (DCR) Up to 2 years Defined as the proportion of patients with a complete response, partial response or stable disease to treatment according to RECIST1.1
Trial Locations
- Locations (1)
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China