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

July 2, 2017 updated by: YuLi, Chinese PLA General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Chinese PLA Gereral Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • rh-endostatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate(RR)
Time Frame: 18months
CR(complete response)+PR(partial response)
18months
clinical benefit rate(CBR)
Time Frame: 24months
CR+PR+SD(stable disease)
24months
overall survival(OS)
Time Frame: 36 months
Overall survival was defined as the time from randomization to death from any cause.
36 months
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
36 months
Quality of life (QOL)
Time Frame: 36months
A questionnaire with questions referred to simple assessments of physical abilities
36months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Yu Li, MD, China PLA hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

July 2, 2017

First Submitted That Met QC Criteria

July 2, 2017

First Posted (Actual)

July 5, 2017

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

July 2, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChinaPLAGH-HCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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