Using targeted radiation therapy for small liver cancer recurrence
A Single-center, Unblinded, Single-arm, Prospective Trial of Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent Hepatocellular Carcinoma
This study is testing whether a special type of targeted radiation therapy can help people with small liver cancer that has come back after surgery or other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05596630 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of stereotactic body radiation therapy (SBRT) in patients with small intrahepatic recurrent hepatocellular carcinoma (HCC) following surgery or local ablation. A total of 40 patients will be enrolled and treated with SBRT without any adjuvant therapy, with follow-up assessments planned to evaluate treatment outcomes. The study aims to provide high-level evidence regarding the use of SBRT for this specific patient population, addressing a significant gap in current treatment options.
Who should consider this trial
Good fit: Ideal candidates include patients with recurrent small HCC who have undergone previous surgery or ablation and meet specific clinical criteria.
Not a fit: Patients with advanced liver cancer, distant metastasis, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective option for patients with recurrent small liver cancer, potentially improving survival rates.
How similar studies have performed: While there is limited high-level evidence for SBRT in this context, similar approaches have shown promise in treating other localized cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Clinical or pathological diagnosis of HCC without lymph node and distant metastasis. 2\. Previous surgery or radiofrequency ablation, no recurrence within 6 months. 3. Early stage liver cancer within Milan criteria : (1) single tumor diameter less than 5 cm; (2) not more than three foci of tumor, each one not exceeding 3 cm; (3) no angioinvasion; (4) no extrahepatic involvement. 4\. The remnant liver volume beyond the radiotherapy target area should be greater than 700ml. 5\. No serious hematological, heart, lung, hepatic, renal dysfunction and immunodeficiency. 6\. Hemoglobin (Hb)≥8g/dL ; white blood cell (WBC) ≥ 2\*10\^9/L ; neutrophils (ANC) ≥ 1.0\* 10\^9/L ; platelet (Pt) ≥ 50\*10\^9/L. 7\. Men or women with fertility are willing to take contraceptive measures in the trial. 8\. ECOG score standard 0 \~ 1 ; child-pugh score A-B . 9. Expected survival period \> 3 months. 10. Voluntary participation and signing of informed consent. Exclusion Criteria: * 1\. Patients who have undergone antitumor therapy for liver cancer. 2. Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points. 3\. Total bilirubin exceed the upper limit of normal 1.5 times, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 2.5 times, ICGR15≥40%. 4\. Patients undergoing major surgery within 1 month of study initiation. 5. Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years). 6\. Participants in other clinical trials within 30 days prior to study treatment. 7\. The distance between the tumor and the gastrointestinal tract \< 0.5 cm. 8. Pregnancy, lactation or those with fertility but without contraceptive measures. 9\. Patients with drug addiction such as drugs, long-term alcoholism, and AIDS. 10. Patients have an uncontrollable epileptic seizure, or lose insight due to mental illness. 11\. Patients with severe allergic history or specific constitution. 12. Researchers consider it inappropriate to participate in the test.
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Weilin Wang, doctor
- Email: wam@zju.edu.cn
- Phone: +86 0571 87783820
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.