Recombinant Human Endostatin(Rh-endostatin) Combine With Radiotherapy in the Treatment of Hepatocellular Carcinoma(HCC)
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|ClinicalTrials.gov Identifier: NCT03208335|
Recruitment Status : Unknown
Verified July 2017 by YuLi, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : July 5, 2017
Last Update Posted : July 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: recombinant human endostatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Of Rh-Endostatin In Combination With Radiotherapy In The Treatment Of Hepatocellular Carcinoma|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: rh-endostatin combination
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
The cycles of rh-endostatin's treatment depends on the effect of reaction and tolerance.
Other Name: rh-endostatin
- progress-free survival(PFS) [ Time Frame: 18 months ]Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
- response rate(RR) [ Time Frame: 18months ]CR(complete response)+PR(partial response)
- clinical benefit rate(CBR) [ Time Frame: 24months ]CR+PR+SD(stable disease)
- overall survival(OS) [ Time Frame: 36 months ]Overall survival was defined as the time from randomization to death from any cause.
- adverse event(AE) [ Time Frame: 36 months ]Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
- Quality of life (QOL) [ Time Frame: 36months ]A questionnaire with questions referred to simple assessments of physical abilities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208335
|Contact: Yu Li, MD||+86 email@example.com|
|Chinese PLA Gereral Hospital||Recruiting|
|Beijing, Beijing, China, 100000|
|Contact: Yu Li, MD +86 15801570739 firstname.lastname@example.org|
|Principal Investigator:||Yu Li, MD||China PLA hospital|