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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT06538623•Ruijin Hospital

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
+11 more criteria

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;
+3 more criteria

Locations (1)

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

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

August 23, 2024

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

August 27, 2024

Enrollment

ESTIMATED participants

Conditions

Pancreatic NeoplasmsNeoplasm MetastasisHepatic Metastasis of Pancreatic Cancer

Interventions

Liposome Irinotecan Injection II combined with Oxaliplatin, Fluorouracil, Leucovorin

DRUG

Tegodor

DRUG

Contacts

Zhongmin Wang

CONTACT

13901848333 wzm11896@rjh.com.cn

Xiaoyu Liu

CONTACT

15121013042 lxy12931@rjh.com.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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