Irinotecan Liposome for Resectable Pancreatic Cancer With or Without Addebelizumab

Sponsor
Zhejiang University
Study ID
NCT06172036
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Neoadjuvant Chemotherapy
  • Resectable Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • irinotecan liposome + oxaliplatin + 5-FU / LV — DRUG
    Efficacy and safety of irinotecan liposome combined with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin calcium (LV) with or without adbellizumab for resectable pancreatic cancer
  • Adebellizumab — DRUG
    Efficacy and safety of irinotecan liposome combined with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin calcium (LV) with or without adbellizumab for resectable pancreatic cancer

Study Details

To evaluate the efficacy and safety of irinotecan liposomes with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin (LV) with or without adelizumab for resectable pancreatic cancer by assessing the 12-month EFS rate

Key Dates

Start date
Jan 20, 2024
Status verified
Dec 2023
Primary completion
Jan 20, 2026
Completion
Jan 20, 2027

Study Design

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

Arms

  • Experimental: Arm A
    Preoperative adliberlizumab + irinotecan liposome + oxaliplatin + 5-FU / LV (28 days as one cycle, 2 treatment cycles). Surgery was performed within 2 to 4 weeks after completion of neoadjuvant therapy and addebelizumab + irinotecan liposomes + oxaliplatin + 5-FU / LV (28 days as one cycle, 4 treatment cycles) within 4 to 6 weeks after surgery, followed by maintenance therapy with addebelizumab until disease progression or intolerable toxicity. The cumulative postoperative duration of adbelizumab should not exceed 1 year. Tumor recurrence, safety and survival follow-up was evaluated after completion of the drug.
  • Experimental: Arm B
    Irinotecan liposome + oxaliplatin + 5-FU / LV (28 days one cycle, 2 treatment cycles), 2-4 weeks after completion of neoadjuvant therapy and 4-6 weeks after surgery, adjuvant irinotecan liposome + oxaliplatin + 5-FU / LV (28 days one cycle, 4 treatment cycles). Tumor recurrence, safety and survival follow-up were performed after the end of the adjuvant treatment phase.
  • Active Comparator: Arm C
    Upfront surgery, and postoperative adjuvant regimen as with ArmB. Tumor recurrence, safety and survival follow-up were performed after the end of the adjuvant treatment phase.

Primary Outcome Measure

12-month EFS rate [ Time Frame: Up to 2 years. ]

Central Contacts

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