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Hepatocellular carcinoma(HCC) is a high malignancy cancer which progress rapidly , and the rates of morbidity and mortality is very high in China. Radiotherapy as a effective treatment is commonly used in unresectable HCC patients. Preclinical models have shown that anti-angiogenesis medicine,such as rh-endostatin, can normalize the tumor vasculature to make it more efficient for oxygen delivery, which can enhance the radiosensitivity subsequently. This study is to evaluate the safety and efficacy of rh-endostatin combined with radiotherapy in the treatment of HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rh-endostatin combination | Experimental | Continuous intravenous pumping (CIP) recombinant human endostatin(rh-endostatin) 30mg/d, from 5 days before radiotherapy,for 7days,21 per cycle.Standard radiotherapy for HCC is conducted concurrently.Those patients will receive 3-5 cycles rh-endostatin after the radiotherapy is finished,4-6 cycles in all. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human endostatin | Drug | The cycles of rh-endostatin's treatment depends on the effect of reaction and tolerance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| progress-free survival(PFS) | Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| response rate(RR) | CR(complete response)+PR(partial response) | 18months |
| clinical benefit rate(CBR) | CR+PR+SD(stable disease) | 24months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Li, MD | Contact | +86 15801570739 | szy957@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Li, MD | China PLA hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA Gereral Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D043169 | Endostatins |
| ID | Term |
|---|---|
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| overall survival(OS) | Overall survival was defined as the time from randomization to death from any cause. | 36 months |
| adverse event(AE) | Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause | 36 months |
| Quality of life (QOL) | A questionnaire with questions referred to simple assessments of physical abilities | 36months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |