A Phase 2 interventional study of Adjuvant SIB radiotherapy in Hepatocellular Carcinoma, Narrow Margin and Radiotherapy, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-16.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment
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.
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's planned enrollment of 100 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.
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Exclusion Criteria:
Adjuvant integrated boost radiotherapy following narrow-margin hepatectomy in patients with HCC.
Radiation: Adjuvant SIB radiotherapy
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 3-year Overall Survival
The 3-year overall survival was calculated from the date of surgical resection to the date of death from any cause.
Time frame: up to 36 months
Disease-free Survival (DFS)
Disease-free survival (DFS) was calculated from the date of surgical resection to the date of the first recurrence or death from HCC
Time frame: up to 36 months
Pattern of Failure
The type of recurrence (locoregional failures or distant failure)
Time frame: up to 36 months
Toxic Events
Toxic events was evaluated during received protocol therapy according to CTCAE 4.03
Time frame: up to 36 months
Local Control Rate
Patients with stable disease \[SD\], partial response \[PR\] or complete response\[CR\] were recorded as local control.
Time frame: up to 36 months
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences