Clinical trial · Interventional
Recombinant Human Endostatin(Rh-endostatin) Combine With Radiotherapy in the Treatment of Hepatocellular Carcinoma(HCC)
A Phase II Trial Of Rh-Endostatin In Combination With Radiotherapy In The Treatment Of Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant human endostatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- rh-endostatin combination
- 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.
- interventionNames
- Drug: recombinant human endostatin
Primary outcomes (1)
- measure
- progress-free survival(PFS)
- timeFrame
- 18 months
- description
- Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
Secondary outcomes (5)
- measure
- response rate(RR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available