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Phase I study for Apatinib combination with intensity-modulated radiotherapy for unresectable hepatocellular carcinoma

Phase I study for Apatinib combination with intensity-modulated radiotherapy for unresectable hepatocellular carcinoma

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018309
Enrollment
Unknown
Registered
2018-09-11
Start date
2017-09-01
Completion date
Unknown
Last updated
2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

Case series:IMRT+ Apatinib

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. aged 18 to 75 years; 2. ECOG performance status between 0 to 1; 3. histologically or cytologically confirmed hepatocellular carcinoma, or meetting the imaging diagnosis of HCC 4. unresectable disease; 5. adequate hematopoietic function (white cell count =3.0 x 10^9/L, absolute neutrophils count =1.5 x 10^9/L, hemoglobin, =100 g/L, platelets = 100 × 10^9/L), hepatc function (Child-Pugh score 5-6, alanine aminotransferase = 2.5 ×ULN, aspartate aminotransferase = 2.5 ×ULN, alkaline phosphatase = 2.5 ×ULN, bilirubin = 1.5 ×ULN, prothrombin time = 1.5 ×ULN, renal function(serum creatinine = 2mg/ml, blood urea nitrogen = 40mg/dl).

Exclusion criteria

Exclusion criteria: 1. ECOG performance status =2; 2. poor hepatc function (Child-Pugh Class C, or Child-Pugh Class B in company with gastrointestinal hemorrhage; 3. hepatic encephalopathy, refractory ascites; 4. Extrahepatic metastasis; 5. Allergic to Apatinib; 6. systemic chemotherapy within 4 weeks; 7. untrolled medical disease.

Design outcomes

Primary

MeasureTime frame
maximum tolerated dose;

Secondary

MeasureTime frame
Dose limiting toxicity;

Countries

China

Contacts

Public ContactWang Wei-hu

Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute

wangweihu88@163.com+86 13611396920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026