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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
YuLi, Chinese PLA General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: recombinant human endostatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. response rate(RR) [ Time Frame: 18months ]
    CR(complete response)+PR(partial response)

  2. clinical benefit rate(CBR) [ Time Frame: 24months ]
    CR+PR+SD(stable disease)

  3. overall survival(OS) [ Time Frame: 36 months ]
    Overall survival was defined as the time from randomization to death from any cause.

  4. 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

  5. Quality of life (QOL) [ Time Frame: 36months ]
    A questionnaire with questions referred to simple assessments of physical abilities



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Yu Li, MD +86 15801570739 szy957@aliyun.com

Locations
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China, Beijing
Chinese PLA Gereral Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Yu Li, MD    +86 15801570739    szy957@aliyun.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Yu Li, MD China PLA hospital
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Responsible Party: YuLi, Vice Director of Department of Radiotherappy, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03208335    
Other Study ID Numbers: ChinaPLAGH-HCC
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by YuLi, Chinese PLA General Hospital:
rh-endostatin
radiotherapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Endostatins
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors