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NCT06532617RecruitingPhase 2

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

A Single-arm Phase II Clinical Study of Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Patients With Advanced Pancreatic Cancer

Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
30 Jul 2024
Start date
19 Sept 2024
Primary completion date
1 Aug 2026
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
NCT number
NCT06532617

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 30
  • From 19 Sept 2024 to the primary completion date, 1 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai General Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.