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

Overview

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.

Full Title of Study: “A Phase II Trial Of Rh-Endostatin In Combination With Radiotherapy In The Treatment Of Hepatocellular Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2018

Interventions

  • Drug: recombinant human endostatin
    • The cycles of rh-endostatin’s treatment depends on the effect of reaction and tolerance.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Chinese PLA General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: YuLi, Vice Director of Department of Radiotherappy – Chinese PLA General Hospital
  • Overall Official(s)
    • Yu Li, MD, Principal Investigator, China PLA hospital
  • Overall Contact(s)
    • Yu Li, MD, +86 15801570739, szy957@aliyun.com

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