Hepatocellular Carcinoma
Conditions
Keywords
rh-endostatin, radiotherapy
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.
Interventions
The cycles of rh-endostatin's treatment depends on the effect of reaction and tolerance.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| response rate(RR) | 18months | CR(complete response)+PR(partial response) |
| clinical benefit rate(CBR) | 24months | CR+PR+SD(stable disease) |
| overall survival(OS) | 36 months | Overall survival was defined as the time from randomization to death from any cause. |
| 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 |
| Quality of life (QOL) | 36months | A questionnaire with questions referred to simple assessments of physical abilities |
Countries
China
Contacts
Primary ContactYu Li, MD
Outcome results
None listed