Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer

Launched by SHANGHAI GENERAL HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with advanced pancreatic cancer. The treatment combines a drug called Cadonilimab with either S-1 or capecitabine, which are types of chemotherapy. The goal is to see how well this combination works and how safe it is for patients who have already received standard treatments. The trial is currently not recruiting participants, but it aims to include adults aged 18 to 80 who have been diagnosed with pancreatic ductal adenocarcinoma and have measurable cancer lesions.

To be eligible for the trial, patients need to have had previous treatments and show that their cancer has not spread to distant parts of the body. They should also have good organ function and be in generally good health. Participants can expect to receive the study medications and undergo monitoring for any side effects during the trial. It’s important to note that those with certain medical conditions, recent participation in other clinical trials, or specific health issues may not qualify for this study.

Gender

ALL

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, 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