NCT05596630 Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent HCC
| NCT ID | NCT05596630 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Carcinoma; Hepatocellular |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-05-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05596630 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Carcinoma; Hepatocellular. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05596630 currently recruiting?
Yes, NCT05596630 is actively recruiting participants. Contact the research team at wam@zju.edu.cn for enrollment information.
Where is the NCT05596630 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05596630 clinical trial?
NCT05596630 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 40 participants.