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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposome Irinotecan Injection II via Hepatic Arterial Infusion Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposome Irinotecan Injection II combined with Oxaliplatin, Fluorouracil, Leucovorin | Drug | 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); |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall Survival | From enrollment to the death from any cause, assessed up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | 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 | Progression Free Survival |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 2000010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37708904 | Background | Wainberg ZA, Melisi D, Macarulla T, Pazo Cid R, Chandana SR, De La Fouchardiere C, Dean A, Kiss I, Lee WJ, Goetze TO, Van Cutsem E, Paulson AS, Bekaii-Saab T, Pant S, Hubner RA, Xiao Z, Chen H, Benzaghou F, O'Reilly EM. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-1281. doi: 10.1016/S0140-6736(23)01366-1. Epub 2023 Sep 11. |
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| Tegodor | Drug | Tegodor: 40 mg per dose, twice daily for seven days, every 3 weeks (Q3W), taken orally. |
|
| From enrollment to tumor progression or date of death from any cause, whichever came first, assessed up to 18 months |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| C036634 | Tegodor 73 |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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