RecruitingPhase 2NCT06538623

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


Sponsor

Ruijin Hospital

Enrollment

40 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a combination of chemotherapy drugs delivered directly into the liver's blood supply (a technique called hepatic artery infusion, or HAIC) for people with pancreatic cancer that has spread only to the liver. The goal is to find out whether this approach works better than standard chemotherapy after previous treatments have stopped working. **You may be eligible if...** - You are 18 or older with pancreatic cancer that has spread only to the liver - Previous standard chemotherapy (AG regimen) has stopped working or caused intolerable side effects - Your overall health and organ function meet certain minimum levels (blood counts, liver and kidney function within acceptable ranges) - You are reasonably functional day-to-day (ECOG score 0–2) **You may NOT be eligible if...** - Your cancer has spread to organs other than the liver - You have significant fluid buildup in your abdomen (ascites) that needs treatment - You have serious heart disease, active hepatitis B, or active infection - You are pregnant or breastfeeding - Your estimated survival is 3 months or less Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLiposome 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);

DRUGTegodor

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


Locations(1)

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

Shanghai, Shanghai Municipality, China

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NCT06538623


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