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

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

NCT ID: NCT06532617

Condition: Pancreatic Neoplasms

Conditions: Official terms:
Pancreatic Neoplasms
Capecitabine

Conditions: Keywords:
PD-1/CTLA-4 Bispecific Antibody

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cadonilimab+S-1or Capecitabine
Description: 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.
Arm group label: Cadonilimab+S-1or Capecitabine

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai General Hospital

Address:
City: Shanghai
Zip: 200040
Country: China

Start date: August 1, 2024

Completion date: August 1, 2027

Lead sponsor:
Agency: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Agency class: Other

Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06532617