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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: recombinant human endostatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03208335

ChinaPLAGH-HCC

Details and patient eligibility

About

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.

Enrollment: 61 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

rh-endostatin combination

Experimental group

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.

Treatment:

Drug: recombinant human endostatin