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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

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‣ 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:

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‣ Normal electrocardiogram (ECG) or ECG abnormalities deemed clinically insignificant by the investigator;

⁃ 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.

Locations
Other Locations
China
Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Zhongmin Wang
wzm11896@rjh.com.cn
13901848333
Backup
Xiaoyu Liu
lxy12931@rjh.com.cn
15121013042
Time Frame
Start Date: 2024-08-23
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

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