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Efficacy and Safety of Serplulimab in Combination With Bevacizumab and FOLFIRINOX or NALIRIFOX as Second-Line Therapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

NCT07733050 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-07-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Serplulimab and Bevacizumab injection

Serplulimab：200 mg, intravenous infusion, Day 1 of each 14-day cycle Bevacizumab：6 mg/kg (second-line) or 5 mg/kg (maintenance), intravenous infusion, Day 1 of each 14-day cycle

DRUG

FOLFIRINOX/NALIRIFOX

FOLFIRINOX:Oxaliplatin 68 mg/m² IV over 2h, Irinotecan 130 mg/m² IV over 30-90 min, Leucovorin 400 mg/m² IV over 2h, Fluorouracil 400 mg/m² IV bolus then 2400 mg/m² continuous IV over 46h, Day 1, every 14 days NALIRIFOX:Oxaliplatin 60 mg/m² IV over 2h, Liposomal Irinotecan 50 mg/m² IV over 90 min, Leucovorin 400 mg/m² IV over 30 min, Fluorouracil 2400 mg/m² continuous IV over 46h, Day 1, every 14 days

DRUG

S-1

Oral, dose per local clinical practice, during maintenance phase

Sponsors & Collaborators

  • Shanghai General Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-08-01
Completion
2028-08-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07733050 on ClinicalTrials.gov