Actively Recruiting
Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent HCC
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-10
40
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary liver cancer is one of the common malignant tumors in China, of which hepatocellular carcinoma (HCC) accounts for 85%-90%. It is worth noting that the recurrence rate of liver cancer is greater than 10% at 1 year after surgery, while the recurrence rate in 5 years reaches 70-80%. Stereotactic body radiation therapy (SBRT) refers to a kind of radiotherapy technology to achieve a steep dose gradient and achieve high-precision position and high-dose fractionated irradiation. The rapid dose drop-down enables SBRT to maximize the protection of normal tissues around the tumor, and it often requires only 1-5 times of high-dose fractionated irradiation to complete the course of treatment.SBRT may play an important role in the treatment of small intrahepatic recurrence HCC, but there is still a lack of evidence of high-level prospective studies. We intend to conduct a single-center, prospective, clinical study to further elaborate the efficacy and safety of SBRT in the treatment of small intrahepatic recurrent HCC.
CONDITIONS
Official 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; no more than three tumors each no larger than 3 cm; no angioinvasion; no spread outside liver
- Remaining liver volume outside radiation area greater than 700 ml
- No serious blood, heart, lung, liver, kidney dysfunction or immune deficiency
- Hemoglobin at least 8 g/dL; white blood cell count at least 2 x 10^9/L; neutrophils at least 1.0 x 10^9/L; platelets at least 50 x 10^9/L
- Men or women able and willing to use contraception during the trial
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Child-Pugh liver function score A or B
- Expected survival longer than 3 months
- Voluntary participation with signed informed consent
You will not qualify if you...
- Previous antitumor therapy for liver cancer
- Severe cirrhosis, recent vomiting blood due to portal hypertension, Child-Pugh score 10 or higher
- Total bilirubin over 1.5 times normal, ALT or AST over 2.5 times normal, ICGR15 40% or higher
- Major surgery within 1 month before study start
- History of other malignancies except certain skin and cervical cancers treated over 3 years ago
- Participation in other clinical trials within 30 days before treatment
- Tumor located less than 0.5 cm from gastrointestinal tract
- Pregnancy, breastfeeding, or fertility without contraception
- Drug addiction, long-term alcoholism, or AIDS
- Uncontrolled epilepsy or mental illness causing loss of insight
- Severe allergic history or specific allergic constitution
- Investigator's judgment that participation is inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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