Actively Recruiting
Firstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced Pancreatic Cancer
Led by Zhejiang Cancer Hospital · Updated on 2025-11-19
292
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A randomized, multicenter, Phase III trial evaluating the efficacy and safety of first-line Sequential AG-mFOLFOX chemotherapy combined with Serplulimab and Bevacizumab versus AG chemotherapy alone in advanced pancreatic cancer. The primary endpoint is Overall Survival (OS). Approximately 292 patients will be enrolled in China.
CONDITIONS
Official Title
Firstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at consent, any gender
- Confirmed pancreatic ductal adenocarcinoma by pathology or cytology
- No prior systemic therapy for unresectable locally advanced or metastatic pancreatic cancer
- Measurable lesions at baseline by RECIST 1.1 criteria
- ECOG performance status of 0 or 1 with expected survival of at least 12 weeks
- No serious diseases of heart, lungs, brain, or other organs
- Adequate organ function including bone marrow, coagulation, liver, kidney, and heart function as detailed in the protocol
- Use of effective contraception during the study and for 6 months after last dose if of childbearing potential
- Ability and willingness to comply with study visits, treatments, and tests
You will not qualify if you...
- Brain or meningeal metastases
- Untreated spinal compression fractures or unstable treated fractures
- High risk of gastrointestinal or abdominal bleeding
- Uncontrolled cancer pain or unstable narcotic analgesics
- Previous treatment with VEGFR inhibitors or immune checkpoint inhibitors
- Antitumor treatments within specified timeframes before enrollment
- Major surgeries or invasive treatments with incomplete healing
- Recent radical radiotherapy or recent palliative radiotherapy exceeding local standards
- Use of systemic corticosteroids or immunosuppressive therapy recently, except certain exceptions
- Uncorrectable low serum albumin levels
- Significant weight loss or worsening ECOG status before enrollment
- Live vaccine use within 28 days prior to enrollment
- Current or past interstitial pneumonia unless inactive
- Pre-existing or current autoimmune diseases except certain stable conditions
- Other malignancies within 5 years except some cured cancers
- Hepatic metastases over 50% of liver volume
- Uncontrolled infections or comorbidities including active HBV, HCV, HIV, syphilis, tuberculosis, serious infections, uncontrolled hypertension, serious cardiac conditions
- Unrecovered toxicity from prior antitumor therapy except certain conditions
- History of allogeneic bone marrow or organ transplantation
- Known allergies or intolerances to study drugs or similar medications
- Pregnant or breastfeeding women
- Other conditions affecting safety or adherence as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
J
Jieer Ying, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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