Actively Recruiting
Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-05-14
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Cadonilimab combined with either S-1 or capecitabine as a second-line treatment for people with advanced pancreatic cancer. This phase II clinical trial focuses on patients who have already received standard first-line treatments and now need further therapy. The study aims to understand how well this combination works and how safe it is for these patients. Participants will receive Cadonilimab intravenously at a dose of 6 mg/kg on day 1 every three weeks. Alongside this, they will take either S-1 orally twice daily at 40-60 mg from day 1 to day 14 every three weeks or capecitabine orally twice daily at 1250 mg/m2 from day 1 to day 14 every three weeks. The choice between S-1 or capecitabine depends on what the patient used in their first-line treatment or the investigator's decision. Treatment continues until the disease progresses or unacceptable side effects occur. During the trial, participants will be monitored closely with assessments to measure tumor response, overall survival, progression-free survival, disease control rate, and duration of response for up to two years. Researchers will also evaluate safety throughout the study. Participants can expect regular visits for evaluations, tests, and monitoring until the study ends or their condition changes.
CONDITIONS
Brief Title
Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Age 18 to 80 years, female or male
- Histopathologically confirmed pancreatic ductal adenocarcinoma
- Locally advanced pancreatic cancer with no distant metastasis and specific tumor involvement as defined
- Previously received standard first-line anti-tumor treatment
- At least one measurable lesion according to RECIST1.1
- ECOG performance status 0-1
- Expected survival time greater than 3 months
- Adequate organ function
You will not qualify if you...
- Malignant diseases other than pancreatic cancer diagnosed within 5 years before first dose (except certain skin cancers)
- Participation in other interventional clinical research or use of research drugs/devices within 4 weeks before first dose
- Active autoimmune disease
- Allogeneic organ or hematopoietic stem cell transplantation
- Allergy to cadonilimab, S-1, capecitabine, or their ingredients
- Not fully recovered from toxicity or complications of prior interventions
- History of HIV
- Active hepatitis B or C virus infection
- Pregnant or breastfeeding women
- Severe or uncontrolled systemic diseases
- Active pulmonary tuberculosis
- Mental disorders preventing cooperation
- Uncontrolled infection
- Investigator's judgment of inability to complete trial or unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or unacceptable toxicity
Participants receive Cadonilimab combined with either S-1 or Capecitabine until disease progression or unacceptable toxicity. The choice between S-1 or Capecitabine depends on prior treatment history or investigator's choice.
Treatment cycles every 3 weeks with oral medication given for 14 days each cycle
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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