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

NCT06205472 | Recruiting Phase 2 DMC

• 1 other identifier: NCC4255
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hepatocellular Carcinoma; Narrow Margin; Radiotherapy

Keywords

Hepatocellular Carcinoma; Narrow Margin; Adjuvant Simultaneously Integrated Boost Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disease-free Survival (DFS)

  up to 36 months

• Pattern of Failure

  up to 36 months

• Toxic Events

  up to 36 months

• Local Control Rate

  up to 36 months

Study Arms (1)

Adjuvant SIB radiotherapy

EXPERIMENTAL

Adjuvant integrated boost radiotherapy following narrow-margin hepatectomy in patients with HCC.

Radiation: Adjuvant SIB radiotherapy

Interventions

Adjuvant SIB radiotherapy RADIATION

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.

Adjuvant SIB radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Bo Chen

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Bo Chen, MD

CONTACT

00861324000876; chenboo@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 16, 2024
• Study Start: January 26, 2024
• Primary Completion: December 12, 2025
• Study Completion (Estimated): December 12, 2026
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

CN (1)