Adjuvant radiotherapy after liver surgery for liver cancer
Phase II Study of Adjuvant Simultaneously Integrated Boost Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
This study is testing a new type of targeted radiation therapy after liver surgery to see if it helps people with liver cancer live longer and stay cancer-free.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06205472 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial investigates the safety and efficacy of adjuvant simultaneously integrated boost (SIB) radiotherapy in patients with hepatocellular carcinoma (HCC) who have undergone narrow-margin hepatectomy. Participants will receive targeted radiotherapy to the high-risk areas of the tumor bed, with specific dosage plans aimed at optimizing treatment while minimizing damage to surrounding healthy tissue. The primary goal is to assess the three-year overall survival rate, while secondary outcomes include disease-free survival, local control rates, and the incidence of toxic events.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a pathological diagnosis of HCC and narrow surgical margins after hepatectomy.
Not a fit: Patients with distant metastasis, prior abdominal irradiation, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and reduce recurrence in patients with HCC after surgery.
How similar studies have performed: Previous studies have shown promising results for adjuvant radiotherapy in similar patient populations, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing
- Bo Chen — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Bo Chen, MD
- Email: chenboo@outlook.com
- Phone: 00861324000876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.