Clinical Study of Effectiveness of Radiotherapy Before Surgery in High-risk Relapse Hepatocellular Cancer Patients

Peking Union Medical College

Status: Unknown

Conditions: Carcinoma, Hepatocellular

Treatments: Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02580929

LC2014B10

Details and patient eligibility

About

This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk relapse hepatocellular cancer patients.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of HCC
2. In high risk of recurrence of HCC but still can endure palliative resection
3. KPS scores are >90
4. With Child-Pugh Class A liver funcion, serum bilirubin< 1.5*normal maxism; ALT and AST< 1.5*normal maxism; normal creatinine and urea nitrogen; WBC>4×109/L, Hb>110g/L, PLT>90X109/L.
5. Have signed informed consent

Exclusion criteria

1. HCC cannot be operated
2. With Child-Pugh Class B/C
3. Have other organ cancer, excluding curative non-melanotic skin cancer and carcinoma in situ of cervix
4. Have other severe disease
5. With active hepatitis
6. Have accepted local radiation therapy in other hospitals
7. KPS scores≤70
8. Tumor edges cannot be defined
9. Have severe cirrhosis complication
10. Intensity modulated radiation therapy cannot reach required dose
11. Cannot cooperate
12. Lactant or pregnant
13. Cannnot be informed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

radiation

Experimental group

Treatment:

Radiation: radiotherapy

no radiation

No Intervention group