Recombinant Human Endostatin(Rh-endostatin) Combine With Radiotherapy in the Treatment of Hepatocellular Carcinoma(HCC)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Trial Of Rh-Endostatin In Combination With Radiotherapy In The Treatment Of Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: recombinant human endostatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed hepatocellular carcinoma,or radiographic indicative HCC with AFP>250ug/l Inoperable and untransplantable,Child-pugh score A or B PS score 0-1 At least one measurable site(diameter >20mm measured by CT or MRI,>10mm measured by helical CT scan. No distant metastases Life expectancy longer than 3 months Willingness and ability to comply the study and signed informed consent. Exclusion Criteria: Not comply the designed treatment or change to other treatment Miss follow-up visits or have incomplete follow-up data The efficacy will not be assessed if the Patient withdrawal the treatment due to severe adverse events(SAE),but SAE will be recorded. Disease progression Patients request to withdraw Patients with III hematologic or Ⅳ nonhematologic drug related toxicity ,or SAE

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rh-endostatin combination<br>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. | Drug: recombinant human endostatin<br>* The cycles of rh-endostatin's treatment depends on the effect of reaction and tolerance.<br>* Other names: rh-endostatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate(RR) | CR(complete response)+PR(partial response) | 18months | 
| clinical benefit rate(CBR) | CR+PR+SD(stable disease) | 24months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rh-endostatin, radiotherapy