Actively Recruiting
Stereotactic Body Radiation Therapy for Safety and Prognosis of Small Recurrent Hepatocellular Carcinoma in a Single-Center Prospective Trial
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-10
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and prognosis of stereotactic body radiation therapy (SBRT) for patients with small recurrent hepatocellular carcinoma (HCC) within the liver after surgery or local ablation therapy. This study focuses on patients with early-stage liver cancer who have experienced recurrence, aiming to provide additional evidence on SBRT's effectiveness and safety. SBRT is a precise, high-dose radiation treatment that may help control tumors while protecting normal liver tissue. Participants will receive SBRT with a radiation dose of at least 40 Gy delivered over 4 to 5 sessions within one week. This single-center, prospective clinical trial will enroll 40 patients who will be monitored without additional therapies. The study does not include a comparison group and is unblinded, focusing solely on SBRT treatment. During the study, patients will be followed for up to 24 months to assess the local control rate of tumors, overall response, survival rates, and progression-free survival. Safety of SBRT will be monitored closely for up to 3 months after treatment. Participants will undergo regular assessments including clinical evaluations and imaging to track tumor status and side effects. The total participation period may extend up to two years to gather comprehensive data on treatment outcomes and safety.
CONDITIONS
Brief Title
Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical or pathological diagnosis of hepatocellular carcinoma without lymph node or distant metastasis
- Previous surgery or radiofrequency ablation with no recurrence within 6 months
- Early stage liver cancer meeting Milan criteria: single tumor less than 5 cm, up to three tumors each not exceeding 3 cm, no angioinvasion, no extrahepatic involvement
- Remnant liver volume outside radiation target area greater than 700 ml
- No serious blood, heart, lung, liver, kidney dysfunction or immunodeficiency
- Hemoglobin ≥ 8 g/dL, white blood cells ≥ 2 x 10^9/L, neutrophils ≥ 1.0 x 10^9/L, platelets ≥ 50 x 10^9/L
- Men or women of reproductive potential willing to use contraception during the trial
- ECOG performance status 0 to 1; Child-Pugh score A to B
- Expected survival longer than 3 months
- Voluntary participation and signed informed consent
You will not qualify if you...
- Previous antitumor therapy for liver cancer
- Severe cirrhosis, recent hematemesis from portal hypertension, Child-Pugh score ≥ 10
- Total bilirubin more than 1.5 times normal, ALT or AST more than 2.5 times normal, ICGR15 ≥ 40%
- Major surgery within 1 month before starting the study
- History of other malignancies except skin basal cell carcinoma or cervical carcinoma in situ treated over 3 years ago
- Participation in other clinical trials within 30 days before study treatment
- Tumor less than 0.5 cm from gastrointestinal tract
- Pregnancy, breastfeeding, or reproductive potential without contraception
- Drug addiction, long-term alcoholism, or AIDS
- Uncontrolled epilepsy or loss of insight due to mental illness
- Severe allergy history or specific sensitivities
- Investigator judgment deeming participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 week
Participants receive stereotactic body radiation therapy (SBRT) for small intrahepatic recurrent hepatocellular carcinoma. The radiation dose is 40Gy or greater over 4 to 5 fractions, completed within 1 week.
4 to 5 visits (in-person)
Duration - Up to 24 months after treatment
Participants are followed up to monitor safety, tumor response, and survival outcomes after SBRT.
Visits at multiple time points over 24 months
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
W
Weilin Wang, doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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