Combining adebelimab with chemotherapy for treating liver metastasis from pancreatic cancer

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

This study is testing if combining a new drug called adebelimab with standard chemotherapy can help people with pancreatic cancer that has spread to the liver feel better and improve their treatment results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: adebelimab, chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06531278 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of adebelimab in combination with irinotecan liposomal injection, oxaliplatin, fluorouracil, and calcium folinate as a first-line treatment for patients with pancreatic cancer that has metastasized to the liver. The study aims to construct a model of immunotherapy combined with chemotherapy to improve treatment outcomes for this aggressive cancer. Participants will receive these treatments and be monitored for their response and any side effects. The trial is designed for patients who have not previously undergone systemic anti-tumor therapy.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with histologically confirmed pancreatic cancer liver metastases who have not received prior systemic anti-tumor treatment.

Not a fit: Patients with central nervous system metastases or those who have received adjuvant therapy within the last six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could significantly improve survival rates and quality of life for patients with advanced pancreatic cancer liver metastasis.

How similar studies have performed: While there have been various approaches to treating pancreatic cancer, the combination of immunotherapy with this specific chemotherapy regimen is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Patients voluntarily join this study and sign the informed consent form
2. Age: 18-75 years old (inclusive), male or female
3. Histologically confirmed pancreatic cancer liver metastases and no previous treatment of any systemic anti-swelling tumor treatment
4. No central nervous system metastases
5. No adjuvant therapy within 6 months prior to enrollment
6. ECOG PS: 0\~1 points
7. Estimated survival ≥ 12 weeks
8. 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);
9. 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
10. Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the requirements of the protocol.

Exclusion Criteria:

1. Other active malignancies within 5 years or concomitantly
2. 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);
3. 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
4. Coagulation abnormalities (INR\>1.5×ULN, APTT\>1.5×ULN), with: Bleeding tendency
5. Active bleeding
6. Uncontrolled active infection, chronic infectious disease, immunodeficiency syndrome
7. Subjects with known active hepatitis B (HBsAg positive and HBV DNA ≥10 3 copy number or ≥1000 U/ml)
8. Presence of active autoimmune disease or history of autoimmune disease with possible recurrence 9. Known history of severe allergy to the study drug
9. Uncontrolled infection at screening
10. Other patients who are considered by the treating physician to be unsuitable for inclusion

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Long Jiang, MD

Conditions Pancreatic Cancer Metastatic to Liver