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

NCT06531278 | Recruiting Phase 2

• 1 other identifier: MR-31-24-025345
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Construct the model of immunotherapy combined with chemotherapy for the treatment of pancreatic cancer liver metastasis

Conditions

Pancreatic Cancer Metastatic to Liver

Outcome Measures

Primary Outcomes (1)

• ORR

  The proportion of patients whose tumors shrink to a certain amount for a certain period of time and include cases of complete response (CR) and partial response (PR). Calculated as: (CR cases + PR cases) / FAS × 100 (%); FAS (full analysis set) refers to the case of qualified patients, administered more than one case. Tumor remission rates are calculated according to the RECIST guidelines (version 1.1)

  Up to 1 year after the treatment

Study Arms (1)

first-line treatment of pancreatic cancer liver metastasis efficacy and safety

EXPERIMENTAL

Adebelimab combined with irinotecan liposomal injection, oxaliplatin, Fluorouracil and calcium folinate

Drug: Irinotecan liposome; Drug: Adebrelimab; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Calcium folinate

Interventions

Irinotecan liposome DRUG

* Patients are planned to receive irinotecan liposomal (60 mg/m2; d1) of every cycle. * 27 days a cycle

first-line treatment of pancreatic cancer liver metastasis efficacy and safety

Adebrelimab DRUG

* Patients are planned to receive Adebrelimab (20 mg/kg; d1) of every cycle. * 27 days a cycle

first-line treatment of pancreatic cancer liver metastasis efficacy and safety

Oxaliplatin DRUG

* Patients are planned to receive Oxaliplatin (85 mg/m2; d1) of every cycle. * 27 days a cycle

first-line treatment of pancreatic cancer liver metastasis efficacy and safety

Fluorouracil DRUG

* Patients are planned to receive fluorouracil (2400mg/m2; d1) of every cycle. * 27 days a cycle

first-line treatment of pancreatic cancer liver metastasis efficacy and safety

Calcium folinate DRUG

* Patients are planned to receive Calcium folinate (400mg/m2; d1) of every cycle. * 27 days a cycle

first-line treatment of pancreatic cancer liver metastasis efficacy and safety

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Other active malignancies within 5 years or concomitantly
• Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) in accordance with: New York Heart Association (NYHA) criteria grade II or greater cardiac insufficiency or Cardiac ultrasonography: LVEF (left ventricular ejection fraction) \<50%; (2) Instability Stereotyped angina; (3) Myocardial infarction within 1 year prior to the start of study treatment Die; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention: (5) QTc\>450ms (male); QTc\>470ms (Women) (The QTc interval is calculated by Fridericia's formula; If the QTc is abnormal, interval can be used Approximately 2 minutes for three consecutive tests, taking the average);
• Those who have high blood pressure and cannot be reduced to the normal range by antihypertensive drug treatment (admitted Systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (based on 2 measurements of ≥ The mean of the BP readings obtained), which is allowed to be achieved through the use of antihypertensive therapy above parameters
• Coagulation abnormalities (INR\>1.5×ULN, APTT\>1.5×ULN), with: Bleeding tendency
• Active bleeding
• Uncontrolled active infection, chronic infectious disease, immunodeficiency syndrome
• Subjects with known active hepatitis B (HBsAg positive and HBV DNA ≥10 3 copy number or ≥1000 U/ml)
• Presence of active autoimmune disease or history of autoimmune disease with possible recurrence 9. Known history of severe allergy to the study drug
• Uncontrolled infection at screening

Sponsors & Collaborators

• Jiang Long: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Interventions

irinotecan sucrosofate; Oxaliplatin; Fluorouracil; Leucovorin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Central Study Contacts

Long Jiang, MD

CONTACT

18017317460; jiang.long@shgh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician of hepatobiliary and pancreatic surgery

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 31, 2024
• Study Start: July 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

CN (1)