Adebelimab Combined With Irinotecan Liposomal Injection, Oxaliplatin, Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cancer Liver Metastasis Efficacy and Safety

Sponsor
Jiang Long
Study ID
NCT06531278
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pancreatic Cancer Metastatic to Liver

Eligibility Criteria

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

Interventions

  • Irinotecan liposome — DRUG
    * Patients are planned to receive irinotecan liposomal (60 mg/m2; d1) of every cycle. * 27 days a cycle
  • Adebrelimab — DRUG
    * Patients are planned to receive Adebrelimab (20 mg/kg; d1) of every cycle. * 27 days a cycle
  • Oxaliplatin — DRUG
    * Patients are planned to receive Oxaliplatin (85 mg/m2; d1) of every cycle. * 27 days a cycle
  • Fluorouracil — DRUG
    * Patients are planned to receive fluorouracil (2400mg/m2; d1) of every cycle. * 27 days a cycle
  • Calcium folinate — DRUG
    * Patients are planned to receive Calcium folinate (400mg/m2; d1) of every cycle. * 27 days a cycle

Study Details

1. Evaluation of adebelimab in combination with irinotecan liposomes, oxaliplatin, fluorouracil, efficacy and safety of leucovorin in the first-line treatment of advanced metastatic pancreatic cancer 2. Construct the model of immunotherapy combined with chemotherapy for the treatment of pancreatic cancer liver metastasis

Key Dates

Start date
Jul 16, 2024
Status verified
Jul 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: first-line treatment of pancreatic cancer liver metastasis efficacy and safety
    Adebelimab combined with irinotecan liposomal injection, oxaliplatin, Fluorouracil and calcium folinate

Primary Outcome Measure

ORR [ Time Frame: Up to 1 year after the treatment ]

Central Contacts