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Trial Title:
Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
NCT ID:
NCT06205472
Condition:
Hepatocellular Carcinoma
Narrow Margin
Radiotherapy
Conditions: Official terms:
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular Carcinoma
Narrow Margin
Adjuvant Simultaneously Integrated Boost Radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Adjuvant SIB radiotherapy
Description:
Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor
bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy,
in 23-25 fractions,mainly depending on the dose constraints of OARs.
Arm group label:
Adjuvant SIB radiotherapy
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 patients with HCC. Eligibility patients will receive
IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95%
GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly
depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the
secondary endpoints are disease-free survival, patterns of failure, toxic events and
local control rate.
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 radiotherapy is an effective, tolerable, and promising adjuvant
regimen in patients with narrow-margin(<1cm) after hepatectomy. The 3-year and 5-year OS
rates of 88.2% and 72.2% were significantly higher than the expected rates based on
published reports and exceeded our predetermined threshold. However, there is no standard
for the prescription dose. The high risk area of recurrence is mostly close to the blood
vessels in the tumor bed, and simultaneously integrated boost (SIB) technique can
optimize the target dose while protecting normal tissues. So, the investigators conducted
this single-arm prospective phase II clinical trial to investigate the efficacy and
safety of adjuvant SIB radiotherapy following narrow-margin(<1cm) hepatectomy in patients
with HCC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Bo Chen
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Chen
Phone:
00861324000876
Email:
chenboo@outlook.com
Investigator:
Last name:
Yirui Zhai
Email:
Sub-Investigator
Investigator:
Last name:
Bo Chen
Email:
Principal Investigator
Start date:
January 26, 2024
Completion date:
December 12, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06205472
