Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer
Recruiting · NCT06532617 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Cadonilimab+S-1or Capecitabine
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Shanghai General Hospital - Shanghai, Shanghai Municipality, China