Using targeted radiation therapy for small liver cancer recurrence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.