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

Phase 2

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: recombinant human endostatin

• Registration Number: NCT03208335
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-02
• Study First Submitted QC: 2017-07-02
• Last Update Submitted: 2017-07-02
• Study First Posted: 2017-07-05
• Last Update Posted: 2017-07-05
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rh-endostatin combination	recombinant human endostatin	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.

Primary Outcome Measures

Name	Time	Method
progress-free survival(PFS)	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

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

Trial Locations

Locations (1)

Chinese PLA Gereral Hospital; 🇨🇳 Beijing, Beijing, China