Efficacy and Safety of Serplulimab in Combination With Bevacizumab and FOLFIRINOX or NALIRIFOX as… (NCT07733050) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of Serplulimab in Combination With Bevacizumab and FOLFIRINOX or NALIRIFOX as Second-Line Therapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
China34 participantsStarted 2026-08-01
Plain-language summary
This is an investigator-initiated, open-label, single-arm, phase II trial evaluating the efficacy and safety of serplulimab (an anti-PD-1 monoclonal antibody) plus bevacizumab, combined with either FOLFIRINOX or NALIRIFOX chemotherapy, as second-line treatment for metastatic pancreatic ductal adenocarcinoma. The study will enrol up to 34 patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Voluntary participation with signed written informed consent, good compliance, and willingness to adhere to follow-up visits.
* Age ≥ 18 years, male or female.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 and life expectancy ≥ 3 months.
* Histologically or cytologically confirmed locally advanced unresectable or metastatic pancreatic adenocarcinoma.
* Must have received prior first-line (1L) systemic therapy. Prior neoadjuvant or adjuvant chemotherapy is allowed if the last treatment was administered \> 6 months before disease recurrence/progression.
* No prior exposure to irinotecan or oxaliplatin.
* At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Adequate major organ function, defined as follows:
Hematology: Hemoglobin ≥ 90 g/L (no transfusion within 14 days); Absolute Neutrophil Count ≥ 1.5 × 10⁹/L; Platelets ≥ 75 × 10⁹/L.
Biochemistry: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 3 × ULN (or ≤ 5 × ULN in the presence of liver metastases); Serum creatinine ≤ 1 × ULN with calculated creatinine clearance \> 50 mL/min (Cockcroft-Gault formula).
Coagulation: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN (or within therapeutic range for patients on stable anticoagulation).
Thyroid: Normal TSH, or abnormal TSH with normal FT3/FT4 (e.g., controlled hypothyroidism).
Cardiac: QTc interval (Fridericia's formula) …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival (OS)
Timeframe: From date of first dose to date of death from any cause, assessed up to approximately 24 months (or up to the end of study).