Oxaliplatin Combined With Irinotecan Liposome Injection II Through Hepatic Artery Infusion (HAIC) Followed by 5-FU/LV (HAIC) or Tegorgor Oral Combination Therapy for Hepatic Metastasis of Pancreatic Cancer

Last updated: August 26, 2024
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Digestive System Neoplasms

Neoplasms

Primary Biliary Cholangitis

Treatment

Tegodor

Liposome Irinotecan Injection II combined with Oxaliplatin, Fluorouracil, Leucovorin

Clinical Study ID

NCT06538623
2024-246
  • Ages > 18
  • All Genders

Study Summary

The study explores the efficacy and safety of oxaliplatin combined with irinotecan liposome injection II via hepatic arterial infusion (HAIC) followed by sequential treatment with 5-FU/LV (HAIC) or oral administration of S-1 in patients with liver metastasis from pancreatic cancer after the failure of first-line treatment with the AG regimen. This research aims to accumulate more clinical evidence and treatment options for second-line therapy in metastatic pancreatic cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18 years and above, with no gender restrictions;

  • Pathologically confirmed pancreatic cancer (originating from the pancreatic ductalepithelium), with clinical records indicating metastatic pancreatic cancer, withmetastasis limited to the liver;

  • Clinical records indicating previous failure of standard AG treatment (havingreceived at least one cycle of standardized chemotherapy, with disease progressionor 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:

  5. Total bilirubin ≤ 2× upper limit of normal (ULN) (for subjects with biliaryobstruction, after biliary drainage ≤ 2.5 × ULN);

  6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) inmetastatic subjects ≤ 5 × ULN;

  7. Albumin level ≥ 28 g/L;

  8. Creatinine clearance rate ≥ 60 ml/min; c. Cardiac function tests:

  9. Normal electrocardiogram (ECG) or ECG abnormalities deemed clinicallyinsignificant by the investigator;

  10. Left ventricular ejection fraction (LVEF) ≥ lower limit of normal;

  • At least 3 weeks post-surgery, radiotherapy, chemotherapy, or other anti-tumortreatments, with general physical condition or related adverse reactions havingrecovered (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

Exclusion Criteria:

  • Metastatic pancreatic cancer with metastasis to organs other than the liver;

  • Subjects with ascites requiring clinical intervention (including moderate to largeamounts of ascites; subjects with ascites need to be stable for more than 4 weeksafter drainage);

  • Clinically severe gastrointestinal diseases (including bleeding, infectiousinflammation, 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, basalcell, or squamous cell skin cancer; subjects with other previous tumors can beenrolled 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 unstableangina; ③ myocardial infarction or stroke within 6 months; ④ supraventricular orventricular arrhythmias requiring treatment or intervention; ⑤ uncontrolledhypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg despite optimal treatment);

  • Known active hepatitis B subjects (HBsAg positive and HBV DNA ≥ 10³ copies or ≥ 1000U/ml);

  • Active infection or unexplained fever > 38.5°C during the screening period or onthe day of administration (subjects with fever caused by tumors can be enrolled asjudged by the investigator), which, in the investigator's judgment, would affectthe subject's participation in this trial or interfere with the evaluation ofefficacy;

  • Known allergy to any components of irinotecan hydrochloride liposome, otherliposomes, oxaliplatin, 5-FU, LV, or S-1;

  • Pregnant or breastfeeding women;

  • Women of childbearing potential with a positive blood (urine) pregnancy test duringthe screening period (both male and female subjects should use reliablecontraception during the trial and for 3 months after the last dose to preventpregnancy);

  • Subjects with other medical or social issues that, in the investigator'sjudgment, might affect their ability to sign informed consent, participation in thetrial, or interpretation of the trial results;

  • Patients with an estimated survival time of ≤ 3 months are not included in thisstudy.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Tegodor
Phase: 2
Study Start date:
August 23, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 2000010
    China

    Active - Recruiting

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