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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03208335
• Other study ID #: ChinaPLAGH-HCC
• Status: Recruiting
• Phase: Phase 2
• First received: July 2, 2017
• Last updated: July 2, 2017
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2017
• Source: Chinese PLA General Hospital
• Contact: Yu Li, MD
• Phone: +86 15801570739
• Email: szy957[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ? nonhematologic drug related toxicity ,or SAE

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Chinese PLA Gereral Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

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