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To evaluate efficacy and safety of irinotecan hydrochloride liposome in combination with 5-FU/LV as second-line treatment for locally advanced or metastatic pancreatic cancer after treatment failure with gemcitabine-based therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | Irinotecan liposome plus 5-fluorouracil, Leucovorin |
|
| Treatment group B | Active Comparator | Placebo plus 5-fluorouracil, Leucovorin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan liposome、5-Fluorouracil、Leucovorin | Drug | Irinotecan liposome、5-Fluorouracil、Leucovorin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | OS is defined as the time from randomization to death due to any cause, or censored at date last known alive. | The maximum time in follow up was approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurs first. | The maximum time in follow up was 12 months |
| Objective Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39300077 | Derived | Cui J, Qin S, Zhou Y, Zhang S, Sun X, Zhang M, Cui J, Fang W, Gu K, Li Z, Wang J, Chen X, Yao J, Zhou J, Wang G, Bai Y, Xiao J, Qiu W, Wang B, Xia T, Wang C, Kong L, Yin J, Zhang T, Shen X, Fu D, Gao C, Wang H, Wang Q, Wang L. Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial. Signal Transduct Target Ther. 2024 Sep 19;9(1):248. doi: 10.1038/s41392-024-01948-4. |
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A randomized, double-blind, single-dummy, parallel-controlled, multicentre study
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| Placebo、5-Fluorouracil、Leucovorin | Drug | Placebo、5-Fluorouracil、Leucovorin |
|
Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| Assessment every 6 weeks after initial response; maximum time on study 12 months |
| Time to Treatment Failure | Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death. | The maximum time in follow up was 12 months |
| Percentage of Patients With Tumor Marker (CA 19-9) Response | Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period. | Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months |
| Quality of life(QoL) | QoL was based on EORTC-QLQ-C30 | Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months |