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To determine the safety and tolerability of irinotecan liposome in combination with oxaliplatin and 5-FU/LV in subjects with advanced pancreatic cancer who have not received prior systemic chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irinotecan liposomeï¼›oxaliplatinï¼›5-FU(Fluorouracil Injection)ï¼›LV(Calcium Folinate Injection) | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan liposomeï¼›oxaliplatinï¼›5-FU(Fluorouracil Injection)ï¼›LV(Calcium Folinate Injection) | Drug | irinotecan liposome in combination with oxaliplatin and 5-FU/LV |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD | Maximum tolerated dose for patients in combination treatment. | 18 months |
| RP2D | Recommended phase II dose for patients in combination treatment. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of AEs/SAEs as Assessed by CTCAE v5.0 | Through laboratory test, physical examination, vital signs,12-lead electrocardiogram (ECG), Echocardiogram, etc.; | From first dose to death; until the data cut off 18 months after the last subject is enrolled. The minimum time in follow up was 18 months. |
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Inclusion Criteria:
Exclusion Criteria:
1)Previously received treatment with irinotecan-containing regimens; 2)Received concomitant medications containing strong inhibitors/strong inducers of CYP3A4 or strong inhibitors of UGT1A1 within two weeks before enrollment; 3)Received the last anti-cancer treatment (including surgery, radiotherapy, etc.) within four weeks before enrollment; 4)Have received treatment with any other investigational drug/device within four weeks before enrollment; 5)Enrolled in another clinical study at the same time unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up.
7.Having experienced an arteriovenous thrombotic event, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism, within one year before enrollment; 8.Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within one year; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
9.Patients who have suffered from malignant tumors other than pancreatic cancer before using the study drug for the first time, except those with low risk of metastasis and death (5-year survival rate >90%), such as adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin; 10.Have any contraindication to either irinotecan liposome, irinotecan, 5-FU, calcium folinate, or oxaliplatin;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40619376 | Derived | Xu Q, Zhao X, Wang X, Zhu R, Cheng Y, Xia T, Wu H, Tian H, Sun Y, Zhang M, Gao C, Fu D, Wu X, Zheng T, Yin X, Chen Y, Chen X, Li Z, Chen R, Yang X, Wang H, Wang Q, Han X, Wu W. Phase 1 trial of HR070803 (an Irinotecan liposome) in combination with 5-fluorouracil, leucovorin, and oxaliplatin for untreated advanced or metastatic pancreatic ductal adenocarcinoma. BMC Med. 2025 Jul 7;23(1):402. doi: 10.1186/s12916-025-04234-4. |
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A dose-escalation and expansion study
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| Objective Response Rate (ORR) |
Number of reported responses (complete [CR] and partial [PR]) divided by the number of reported assessable patients. |
| From first dose to death; until the data cut off 18 months after the last subject is enrolled. The minimum time in follow up was 18 months. |
| Disease Control Rate (DCR) | Based on investigator reviewed radiographic tumour assessment and death. | From first dose to death; until the data cut off 18 months after the last subject is enrolled. The minimum time in follow up was 18 months |
| Duration of Response (DoR) | Based on investigator reviewed radiographic tumour assessment and death. | From first dose to death; until the data cut off 18 months after the last subject is enrolled. The minimum time in follow up was 18 months. |
| Progression-Free Survival (PFS) | Based on change in tumour per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 | From first dose to death; until the data cut off 18 months after the last subject is enrolled. The minimum time in follow up was 18 months. |
| Overall Survival (OS) | Based on investigator reviewed radiographic tumor assessment and death. | From first dose to death; until the data cut off 18 months after the last subject is enrolled. The minimum time in follow up was 18 months. |
| Cmax | peak plasma concentration | 28days |
| Tmax | time to peak concentration | 28days |
| AUC | area under the plasma concentration versus time curve | 28days |
| t1/2z | elimination half-life | 28days |
| Vss | steady-state apparent volume of distribution | 28days |
| CL | clearance | 28days |