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

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
recombinant human endostatin
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring rh-endostatin, radiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chinese PLA Gereral HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rh-endostatin combination

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 2, 2017
Last Updated
July 2, 2017
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03208335
Brief Title
Recombinant Human Endostatin(Rh-endostatin) Combine With Radiotherapy in the Treatment of Hepatocellular Carcinoma(HCC)
Official Title
A Phase II Trial Of Rh-Endostatin In Combination With Radiotherapy In The Treatment Of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
rh-endostatin, radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rh-endostatin combination
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
recombinant human endostatin
Other Intervention Name(s)
rh-endostatin
Intervention Description
The cycles of rh-endostatin's treatment depends on the effect of reaction and tolerance.
Primary Outcome Measure Information:
Title
progress-free survival(PFS)
Description
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
Time Frame
18 months
Secondary Outcome Measure Information:
Title
response rate(RR)
Description
CR(complete response)+PR(partial response)
Time Frame
18months
Title
clinical benefit rate(CBR)
Description
CR+PR+SD(stable disease)
Time Frame
24months
Title
overall survival(OS)
Description
Overall survival was defined as the time from randomization to death from any cause.
Time Frame
36 months
Title
adverse event(AE)
Description
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
Time Frame
36 months
Title
Quality of life (QOL)
Description
A questionnaire with questions referred to simple assessments of physical abilities
Time Frame
36months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Li, MD
Phone
+86 15801570739
Email
szy957@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Li, MD
Organizational Affiliation
China PLA hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA Gereral Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Li, MD
Phone
+86 15801570739
Email
szy957@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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