NCT03208335

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 5, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

July 2, 2017

Last Update Submit

July 2, 2017

Conditions

Hepatocellular Carcinoma

Keywords

rh-endostatinradiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • response rate(RR)

    18months

  • clinical benefit rate(CBR)

    24months

  • overall survival(OS)

    36 months

  • adverse event(AE)

    36 months

  • Quality of life (QOL)

    36months

Study Arms (1)

rh-endostatin combination

EXPERIMENTAL

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

Interventions

recombinant human endostatinDRUG

The cycles of rh-endostatin's treatment depends on the effect of reaction and tolerance.

Also known as: rh-endostatin
rh-endostatin combination

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 â…£ nonhematologic drug related toxicity ,or SAE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA Gereral Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Endostatins

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Angiostatic ProteinsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsCollagen Type XVIIINon-Fibrillar CollagensCollagenExtracellular Matrix ProteinsScleroproteinsBiological Factors

Study Officials

  • Yu Li, MD

    China PLA hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Li, MD

CONTACT

+86 15801570739szy957@aliyun.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director of Department of Radiotherappy

Study Record Dates

First Submitted

July 2, 2017

First Posted

July 5, 2017

Study Start

January 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

July 5, 2017

Record last verified: 2017-07

Locations

CN(1)