Combining oxaliplatin and irinotecan for treating liver metastasis from pancreatic cancer

Single-arm, Open-label Clinical Study of Oxaliplatin Combined With Irinotecan Liposome Injection II Through Hepatic Artery Infusion (HAIC) Followed by 5-Fluorouracil/Leucovorin (HAIC) or Tegorgor Oral Combination Therapy for Hepatic Metastasis of Pancreatic Cancer After First-line Therapy Failure With AG Regimen

This study is testing a new combination of treatments for patients with liver metastasis from pancreatic cancer who haven't improved with their first treatment to see if it can help them better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06538623 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of a combination treatment involving oxaliplatin and irinotecan liposome injection administered through hepatic artery infusion, followed by either 5-FU/LV or oral tegogor therapy. It targets patients with liver metastasis from pancreatic cancer who have not responded to first-line AG treatment. The goal is to gather clinical evidence to enhance second-line treatment options for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed metastatic pancreatic cancer limited to the liver and who have previously failed standard AG treatment.

Not a fit: Patients with pancreatic cancer that has metastasized beyond the liver or those who have not received prior AG treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with liver metastasis from pancreatic cancer who have limited treatment choices.

How similar studies have performed: While there have been studies exploring similar combination therapies, this specific approach using hepatic artery infusion with these agents is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Aged 18 years and above, with no gender restrictions;
* Pathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records indicating metastatic pancreatic cancer, with metastasis limited to the liver;
* Clinical records indicating previous failure of standard AG treatment (having received at least one cycle of standardized chemotherapy, with disease progression or intolerance during treatment, or disease progression after the end of treatment);
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
* Adequate organ function, meeting the following criteria:

  a. Hematological tests:
  1. Neutrophils ≥ 1.5 × 10⁹ /L;
  2. White blood cells ≥ 3.0 × 10⁹ /L;
  3. Platelets ≥ 85 × 10⁹ /L;
  4. Hemoglobin ≥ 70 g/L; b. Biochemical tests:

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  1. Total bilirubin ≤ 2× upper limit of normal (ULN) (for subjects with biliary obstruction, after biliary drainage ≤ 2.5 × ULN);
  2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in metastatic subjects ≤ 5 × ULN;
  3. Albumin level ≥ 28 g/L;
  4. Creatinine clearance rate ≥ 60 ml/min; c. Cardiac function tests:

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  1. Normal electrocardiogram (ECG) or ECG abnormalities deemed clinically insignificant by the investigator;
  2. Left ventricular ejection fraction (LVEF) ≥ lower limit of normal;
* At least 3 weeks post-surgery, radiotherapy, chemotherapy, or other anti-tumor treatments, with general physical condition or related adverse reactions having recovered (toxicity ≤ grade 1) or stabilized;
* Willing to participate and sign the informed consent form;
* Good compliance and agreement to cooperate with survival follow-up.

Exclusion Criteria:

* Metastatic pancreatic cancer with metastasis to organs other than the liver;
* Subjects with ascites requiring clinical intervention (including moderate to large amounts of ascites; subjects with ascites need to be stable for more than 4 weeks after drainage);
* Clinically severe gastrointestinal diseases (including bleeding, infectious inflammation, perforation, obstruction, or diarrhea greater than grade 1);
* NRS pain score ≥ 4 after standardized treatment with analgesics;
* Second primary malignancy within 5 years (except cured carcinoma in situ, basal cell, or squamous cell skin cancer; subjects with other previous tumors can be enrolled if there has been no recurrence within 5 years);
* Uncontrolled cardiovascular or cerebrovascular diseases with clinical symptoms, including but not limited to: ① NYHA class III or higher heart failure; ② unstable angina; ③ myocardial infarction or stroke within 6 months; ④ supraventricular or ventricular arrhythmias requiring treatment or intervention; ⑤ uncontrolled hypertension (systolic blood pressure \&gt; 150 mmHg and/or diastolic blood pressure \&gt; 90 mmHg despite optimal treatment);
* Known active hepatitis B subjects (HBsAg positive and HBV DNA ≥ 10³ copies or ≥ 1000 U/ml);
* Active infection or unexplained fever \&gt; 38.5°C during the screening period or on the day of administration (subjects with fever caused by tumors can be enrolled as judged by the investigator), which, in the investigator\&#39;s judgment, would affect the subject\&#39;s participation in this trial or interfere with the evaluation of efficacy;
* Known allergy to any components of irinotecan hydrochloride liposome, other liposomes, oxaliplatin, 5-FU, LV, or S-1;
* Pregnant or breastfeeding women;
* Women of childbearing potential with a positive blood (urine) pregnancy test during the screening period (both male and female subjects should use reliable contraception during the trial and for 3 months after the last dose to prevent pregnancy);
* Subjects with other medical or social issues that, in the investigator\&#39;s judgment, might affect their ability to sign informed consent, participation in the trial, or interpretation of the trial results;
* Patients with an estimated survival time of ≤ 3 months are not included in this study.

Where this trial is running

Shanghai, Shanghai

• Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Zhongmin Wang

Conditions Pancreatic Neoplasms; Neoplasm Metastasis; Hepatic Metastasis of Pancreatic Cancer