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Phase I, single-arm exploratory study of radiotherapy (photon) based on the effect and safety of ''anatomical liver segment of anatomical liver resection''

Phase I, single-arm exploratory study of radiotherapy (photon) based on the effect and safety of ''anatomical liver segment of anatomical liver resection''

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048598
Enrollment
Unknown
Registered
2021-07-11
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

Hepatocellular carcinoma

Interventions

treament group:Radiotherapy(photon) based on "anatomical liver resection"

Sponsors

The Affiliated Tumor Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed or in line with the clinical diagnostic criteria for hepatocellular carcinoma. 2. Aged 18 to 75 years, male or female; 3. The tumor is single, the largest diameter is 30x10^9/L; white blood cell count>3x10^9/L or absolute neutrophil value (ANC)>1.5x10^9/L; hemoglobin>90g/L; serum creatinine <2.0 mg/dL; serum alanine aminotransferase and aspartate aminotransferase do not exceed 2.5 times the upper limit of normal; serum total bilirubin does not exceed the upper limit of normal 2 times the limit value; 5. The general condition is good, the ECOG score is 0-2; 6. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Intrahepatic spread or extrahepatic metastasis of tumor, portal vein tumor thrombus; 2. Patients with a history of hepatic encephalopathy or ascites in West Haven classification III grade IV; 3. Patients with a history of other malignancies other than primary HCC, except for skin squamous cell carcinoma or basal cell carcinoma; 4. Patients with a history of upper abdominal radiotherapy; 5. In the radiotherapy plan, patients who fail to comply with the radiation dose limitation of vital organs, including patients whose normal liver tissue volume is less than 700 ml in the radiotherapy plan; 6. Patients with significant concurrent diseases, such as: (1) Active coronary artery disease or a history of myocardial infarction within the past 6 months; (2) Heart failure with New York Heart Association (NYHA) class > 2; (3) Receive hemodialysis or peritoneal dialysis; (4) Active and uncontrolled infections, except chronic viral hepatitis; (5) Human immunodeficiency virus (HIV) infection; (6) uncontrollable or difficult-to-control diabetes; (7) Active gastrointestinal bleeding without definitive treatment within 30 days; (8) Receive organ transplantation, including but not limited to liver transplantation; (9) A history of alcohol or drug abuse within 3 months; (10) Other unstable mental illnesses, abnormal test results or other comorbidities (in the opinion of the investigator, these conditions make the patient participate in the study with unsafe factors, or may affect study compliance or study results); 7. Female patients who are pregnant, lactating or planning to conceive.

Design outcomes

Primary

MeasureTime frame
safety;

Secondary

MeasureTime frame
Objective response rate;Overall survival;

Countries

China

Contacts

Public ContactLiu Jingfeng

Fujian Cancer Hospital

5826181@qq.com+86 13905029580

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026