Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer
Recruiting
Phase 2Interventional Study
Pancreatic Neoplasms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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, chemotherap…
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
Contacts
No contact information available.
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