Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer

Sponsor
CSPC Ouyi Pharmaceutical Co., Ltd.
Study ID
NCT06571461
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Liposomal Irinotecan — DRUG
    Liposomal Irinotecan：i.v. infusion
  • Oxaliplatin — DRUG
    Oxaliplatin;：i.v. infusion
  • S-1 — DRUG
    S-1: Oral
  • Gemcitabine — DRUG
    Gemcitabine: i.v. infusion
  • Capecitabine — DRUG
    Capecitabine: Oral

Study Details

This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.

Key Dates

Start date
Sep 30, 2024
Status verified
Aug 2024
Primary completion
Jan 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
408 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NASOX：Liposomal Irinotecan; Oxaliplatin; S-1
    Liposomal irinotecan at a dose of 50 mg/m² is administered intravenously over 90 minutes on D1. Oxaliplatin is administered at a dose of 60 mg/m² intravenously over 2 hours on D1. S-1 at a dose of 40 to 60mg twice daily is taken orally for 7 consecutive days, followed by a 7-day break. These medications are administered once every 2 weeks for a total of 12 cycles.
  • Active Comparator: GX：Gemcitabine; Capecitabine
    Gemcitabine at a dose of 1000mg/m² is administered via intravenous infusion over 30 minutes on D1, 8, and 15 of a 28-day cycle. Capecitabine at a dose of 1660mg/m² per day in two divided oral doses is taken for 21 consecutive days, followed by a 7-day rest period. These medications are administered once every 4 weeks for a total of 6 cycles.

Primary Outcome Measure

Disease-free survival (DFS) [ Time Frame: Approximately 3 years. ]

Central Contacts

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