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

March 23, 2026 updated by: Zhongmin Wang, Ruijin Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 2000010
        • Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:
    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:
    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 > 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 ≥ 1000 U/ml);
  • Active infection or unexplained fever > 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's judgment, would affect the subject'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'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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liposome Irinotecan Injection II via Hepatic Arterial Infusion Group
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
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);
Drug: Tegodor
Tegodor: 40 mg per dose, twice daily for seven days, every 3 weeks (Q3W), taken orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From enrollment to the death from any cause, assessed up to 18 months
Overall Survival
From enrollment to the death from any cause, assessed up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: From enrollment to tumor response or date of death from any cause, whichever came first, assessed up to 18 months
Objective Response Rate (according to RECIST 1.1 criteria)
From enrollment to tumor response or date of death from any cause, whichever came first, assessed up to 18 months
PFS
Time Frame: From enrollment to tumor progression or date of death from any cause, whichever came first, assessed up to 18 months
Progression Free Survival
From enrollment to tumor progression or date of death from any cause, whichever came first, assessed up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

August 4, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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