Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.

Hepatocellular Carcinoma Clinical Trial

Official title:

Phase II Study of Adjuvant Simultaneously Integrated Boost Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205472
• Other study ID #: NCC4255
• Status: Recruiting
• Phase: Phase 2
• Start date: January 26, 2024
• Est. completion date: December 12, 2026

Study information

• Verified date: January 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Bo Chen, MD
• Phone: 00861324000876
• Email: chenboo[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 12, 2026
• Est. primary completion date: December 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Radiotherapy

Intervention

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.

Locations

Country	Name	City	State
China	Bo Chen	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 36 months
Secondary	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	up to 36 months
Secondary	Pattern of Failure	The type of recurrence (locoregional failures or distant failure)	up to 36 months
Secondary	Toxic Events	Toxic events was evaluated during received protocol therapy according to CTCAE 4.03	up to 36 months
Secondary	Local Control Rate	Patients with stable disease [SD], partial response [PR] or complete response[CR] were recorded as local control.	up to 36 months