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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Patients voluntarily join this study and sign the informed consent form

• Age: 18-75 years old (inclusive), male or female

• Histologically confirmed pancreatic cancer liver metastases and no previous treatment of any systemic anti-swelling tumor treatment

• No central nervous system metastases

• No adjuvant therapy within 6 months prior to enrollment

• ECOG PS: 0\

‣ 1 points

• Estimated survival ≥ 12 weeks

• Normal function of major organs, meeting the following requirements (7 prior to initiation of study treatment days): (1) Routine blood examination: (No blood transfusion and no use of granules within 14 days before screening.) Cell colony-stimulating factor \[G-CSF\], not corrected with medication):1) Hemoglobin \[HB\]≥90g/L; 2) Absolute neutrophil count \[ANC\] ≥1.5×10 9 /L; 3) Platelets \[PLT\] ≥80×10 9 /L; (2) Blood biochemistry tests must meet the following criteria (no transfusion in the 14 days before screening Protein): 1) Serum total bilirubin \[TBIL\] ≤ 1.5 times the upper limit of normal (ULN); 2) Alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\]\<2.5×ULN ; If there is liver metastasis, ALT and AST≤5×ULN; 3) Blood creatinine \[Cr\]≤1×ULN or endogenous creatinine clearance rate \> 50ml/min (Cockcroft-Gault formula); (3) International normalized ratio \[INR\] ≤ 2.3 or prothrombin time \[PT\] exceeding Over the range of normal controls≤6 seconds: (4) Urine protein \< 2+ (if urine protein ≥ 2+, you can urinate eggs for 24 hours White quantitative, 24-hour urine protein quantification \<1.0g can be enrolled);

• Women of childbearing potential must have a pregnancy test (serum or urine) within 7 days prior to enrollment The result is negative and voluntarily during the observation period and after the last dose of study drug8 Use of appropriate methods of contraception within a week; For males, it should be surgically sterile, or Agrees to adopt appropriate during the observation period and for 8 weeks after the last dose of study drug method contraception

⁃ Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the requirements of the protocol.

Locations
Other Locations
China
Shanghai General Hospital
RECRUITING
Shanghai
Contact Information
Primary
Long Jiang, MD
jiang.long@shgh.cn
18017317460
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 40
Treatments
Experimental: first-line treatment of pancreatic cancer liver metastasis efficacy and safety
Adebelimab combined with irinotecan liposomal injection, oxaliplatin, Fluorouracil and calcium folinate
Related Therapeutic Areas
Sponsors
Leads: Jiang Long

This content was sourced from clinicaltrials.gov

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