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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Medpace, Inc. | INDUSTRY |
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This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial. Patients with no tumor lesions one month after resection of hepatocellular carcinoma will be randomized in a 1:1 ratio to 1 of the 2 treatment groups:6mg/d Tyroserleutide (injection), or placebo.
The objective is to evaluate the effect of Injectable Tyroserleutide on the recurrence-free survival,overall survival,quality of life,and the safety and tolerability of subjects after the resection of hepatocellular carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tyroserleutide for injection | Active Comparator | the Tyroserleutide for injection at the dosage of 6mg/d |
|
| the placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil ) | Drug | mitomycin(10mg)+Fluorouracil(1.0g),through the chemoradiative pump,every cycle,5-30 minites; Tyroserleutide for injection(30mg) ,through the micro infusion pump,every cycle,3-5 days |
| Measure | Description | Time Frame |
|---|---|---|
| RFS(Recurrence Free Survival) | The time from randomization to recurrence, metastasis or death due to any reason | 0-2years |
| Measure | Description | Time Frame |
|---|---|---|
| OS (Overall Survival) | The time from randomization to death due to any reason | 0-2years |
| QOL score | Quality of life score | 0-2years |
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Perioperative Period Inclusion Criteria
Signed informed consent;
Aged ≥ 18 years and ≤ 75 years old, male or female;
Subject underwent a complete resection of hepatocellular carcinoma (confirmed by pathology);
The tumor characteristics must meet one of the following:
Tumor thrombosis in the portal vein branches is detected by either;
Tumor thrombosis in the portal vein branches was not detected; and
Perioperative Period Exclusion Criteria
Baseline (Post-SurgeryDay 25 ± 5) Inclusion Criteria
Baseline (Post-SurgeryDay 25 ± 5) Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Tang ZhaoYou, Academician | Shanghai Zhongshan Hospital | Study Chair |
| Wu Meng Chao, Academician | Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital | Study Chair |
| Fan Jia, professor | Shanghai Zhongshan Hospital | Study Director |
| Yang Jia Mei, professor | Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital | Study Director |
| Sun Hui Chuan, professor | Shanghai Zhongshan Hospital | Principal Investigator |
| Yan Yi Qun, professor | Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital | Principal Investigator |
| Zheng Shu Sen, Academician | The First Affiliated Hospital of College of Medicine, Zhejiang Universtiy | Principal Investigator |
| Wu Yu Lian, professor | Second Affiliated Hospital Zhejiang University School of Medicine | Principal Investigator |
| Dong Jia Hong, professor | Chinese PLA General Hospital |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
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| the placebo ,chemotherapy(mitomycin, and Fluorouracil ) | Drug | mitomycin(10mg)+Fluorouracil(1.0g),through the chemoradiative pump,every cycle,5-30 minites; the placebo(30mg) ,through the micro infusion pump,every cycle,3-5 days |
|
| Principal Investigator |
| Sang Xin Ting, professor | Peking Union Medical College Hospital | Principal Investigator |
| Chen Min Shan, professor | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Guo Rong Ping, professor | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Zheng Qi Chang, professor | Tongji Medical College,Huazhong University of Science and Technology Wuhan Union Hospital | Principal Investigator |
| Xia Xiao Qin, professor | Hubei Cancer Hospital | Principal Investigator |
| Liu Jing Feng, professor | First Affiliated Hospital of Fujian Medical University | Principal Investigator |
| Chen Yan Ling, professor | Fujian Medical University Union Hospital | Principal Investigator |
| Ying Min Gang, professor | Fujian Cancer Hospital | Principal Investigator |
| Shi Xue Tao, professor | Shandong Cancer Hospital and Institute | Principal Investigator |
| Liu Jun, professor | Shandong Provincial Hospital | Principal Investigator |
| Liu Ji Yong, professor | Shandong Provincial Hospital | Principal Investigator |
| Wu Jin Shu, professor | Hunan Provincial People's Hospital | Principal Investigator |
| Wang Zhi Ming, professor | Xiangya Hospital of Central South University | Principal Investigator |
| Yang Xun, professor | Sichuan Provincial People's Hospital | Principal Investigator |
| Yan Lv Nan, professor | West China Hospital,Sichuan Universtiy | Principal Investigator |
| Bie Ping, professor | Southwest Hospital, China | Principal Investigator |
| Ma Kuan Sheng, professor | Southwest Hospital, China | Principal Investigator |
| Liu Qing Guang, professor | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Han Ying, professor | Xijing Hospital | Principal Investigator |
| Wang Xue Hao, professor | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Ding Yi Tao, professor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Hao Xi Shan, Academician | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Liu Lian Xin, professor | Center of First Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Li Wei, professor | The First Affiliated Hospital of Jilin University | Principal Investigator |
| Wang Guang Yi, professor | The First Affiliated Hospital of Jilin University | Principal Investigator |
| Jiang Bo, professor | Hunan Provincial People's Hospital | Principal Investigator |
| Du Qin, professor | Second Affiliated Hospital Zhejiang University School of Medicine | Principal Investigator |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C484773 | H-Tyr-Ser-Leu-OH |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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