CompletedPhase 2

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

China40 participantsStarted 2024-08-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:

What they're measuring

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

Trial details

NCT IDNCT06538623

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

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