NCT06205472RecruitingPhase 2
Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
Phase II Study of Adjuvant Simultaneously Integrated Boost Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
Source: ClinicalTrials.gov · Last updated 16 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 25 Dec 2023
- Start date
- 26 Jan 2024
- Primary completion date
- 12 Dec 2025
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06205472
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 26 Jan 2024 to the primary completion date, 12 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had prior abdominal irradiation
- Had prior liver transplantation
- Duration from surgery ≥ 3 months
Other illness
- History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
- Had serious myocardial disease or renal failure
Other
- Had moderate or severe ascites with obvious symptoms
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bo Chen Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.