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

NCT06538623 | Completed Phase 2

• 1 other identifier: 2024-246
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis; Hepatic Metastasis of Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• OS

  Overall Survival

  From enrollment to the death from any cause, assessed up to 18 months

Secondary Outcomes (2)

• ORR

  From enrollment to tumor response or date of death from any cause, whichever came first, assessed up to 18 months

• PFS

  From enrollment to tumor progression or date of death from any cause, whichever came first, assessed up to 18 months

Study Arms (1)

Liposome Irinotecan Injection II via Hepatic Arterial Infusion Group

EXPERIMENTAL

Liposome Irinotecan: 60 mg/m², Oxaliplatin: 85 mg/m², Fluorouracil: 2400 mg/m² Leucovorin: 400 mg/m², every 3 weeks (Q3W), administered via hepatic arterial infusion (HAIC); S-1: 40 mg per dose, twice daily for seven days, every 3 weeks (Q3W), taken orally.

Drug: Liposome Irinotecan Injection II combined with Oxaliplatin, Fluorouracil, Leucovorin; Drug: Tegodor

Interventions

Tegodor DRUG

Tegodor: 40 mg per dose, twice daily for seven days, every 3 weeks (Q3W), taken orally.

Liposome Irinotecan Injection II via Hepatic Arterial Infusion Group

Liposome Irinotecan Injection II combined with Oxaliplatin, Fluorouracil, Leucovorin DRUG

Liposome Irinotecan: 60 mg/m², Oxaliplatin: 85 mg/m², Fluorouracil: 2400 mg/m², Leucovorin: 400 mg/m², every 3 weeks (Q3W), administered via hepatic arterial infusion (HAIC);

Liposome Irinotecan Injection II via Hepatic Arterial Infusion Group

Eligibility Criteria

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

You may qualify if:

• 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:
• Neutrophils ≥ 1.5 × 10⁹ /L;
• White blood cells ≥ 3.0 × 10⁹ /L;
• Platelets ≥ 85 × 10⁹ /L;
• Hemoglobin ≥ 70 g/L; b. Biochemical tests:
• <!-- -->
• Total bilirubin ≤ 2× upper limit of normal (ULN) (for subjects with biliary obstruction, after biliary drainage ≤ 2.5 × ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in metastatic subjects ≤ 5 × ULN;
• Albumin level ≥ 28 g/L;
• Creatinine clearance rate ≥ 60 ml/min; c. Cardiac function tests:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 2000010, China

Location

Related Publications (1)

• Wainberg ZA, Melisi D, Macarulla T, Pazo Cid R, Chandana SR, De La Fouchardiere C, Dean A, Kiss I, Lee WJ, Goetze TO, Van Cutsem E, Paulson AS, Bekaii-Saab T, Pant S, Hubner RA, Xiao Z, Chen H, Benzaghou F, O'Reilly EM. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-1281. doi: 10.1016/S0140-6736(23)01366-1. Epub 2023 Sep 11.

  PMID: 37708904 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

Oxaliplatin; Fluorouracil; Leucovorin; Tegodor 73

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 6, 2024
• Study Start: August 23, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 24, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)