Status:
RECRUITING
Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Hepatocellular Carcinoma
Narrow Margin
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(\<1cm) hepatectomy in pa...
Detailed Description
Surgical resection is the primary treatment for HCC. However, it is associated with a high rate of recurrence and death. Based on the results of our retrospective study and phase II study, adjuvant ra...
Eligibility Criteria
Inclusion
- Pathological diagnosis of HCC after hepatectomy with narrow pathological margins (\< 1 cm)
- Age \> 18 years
- Recovery from surgery with an Eastern Cooperative Oncology Group performance status score of 0 or 1
- Child-Push Score: A5-A6
- Estimated life expectancy \> 3 months
- No distant metastasis (M0)
- Blood routine examination: Hb≥80g/L, ANC≥1.0x10\^9/L, PLT≥50x10\^9/L
- Hepatic function: alanine transaminase(ALT) and aspartate transaminase(AST) ≤1.5 times ULN; or ALT ≤ULN and AST ≤6 times ULN exclude possibility of heart disease
- Renal function: creatinine(CRE) and blood urea nitrogen(BUN)≤1.5 times ULN
- Voluntary to participate and sign informed consent
Exclusion
- History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
- Had prior abdominal irradiation
- Had prior liver transplantation
- Had serious myocardial disease or renal failure
- Had moderate or severe ascites with obvious symptoms
- Duration from surgery ≥ 3 months
Key Trial Info
Start Date :
January 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06205472
Start Date
January 26 2024
End Date
December 12 2026
Last Update
January 16 2024
Active Locations (1)
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1
Bo Chen
Beijing, China