Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent HCC

NCT05596630 | Recruiting

• 1 other identifier: 2022-0771
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma; Hepatocellular

Keywords

Stereotactic Body Radiation Therapy; Recurrent Hepatocellular Carcinoma; Small liver cancer

Outcome Measures

Primary Outcomes (1)

• Local control rate（LC）

  The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (complete response + partial response + stable disease)

  up to 24 months after SBRT

Secondary Outcomes (5)

• Short time Safety profile of SBRT

  up to 3 months after SBRT

• Overall response rate (ORR)

  up to 24 months after SBRT

• Overall survival (OS)

  up to 24 months

• Local recurrence rate (LRR)

  up to 24 months after SBRT

• Progression-free survival (PFS)

  up to 24 months

Study Arms (1)

Stereotactic body radiation therapy

EXPERIMENTAL

Radiation dose: Greater than or equal to 40Gy/4-5F, complete treatment within 1 week.

Radiation: Stereotactic body radiation therapy

Interventions

Stereotactic body radiation therapy RADIATION

Stereotactic body radiotherapy for small intrahepatic recurrent HCC. Radiation dose: Greater than or equal to 40Gy/4-5F, complete treatment within 1 week.

Stereotactic body radiation therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Clinical or pathological diagnosis of HCC without lymph node and distant metastasis.
• \. 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.
• \. The remnant liver volume beyond the radiotherapy target area should be greater than 700ml.
• \. No serious hematological, heart, lung, hepatic, renal dysfunction and immunodeficiency.
• \. 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.
• \. Men or women with fertility are willing to take contraceptive measures in the trial.
• \. ECOG score standard 0 \~ 1 ; child-pugh score A-B . 9. Expected survival period \> 3 months. 10. Voluntary participation and signing of informed consent.

You may not qualify if:

• \. Patients who have undergone antitumor therapy for liver cancer. 2. Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points.
• \. 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%.
• \. 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).
• \. Participants in other clinical trials within 30 days prior to study treatment.
• \. The distance between the tumor and the gastrointestinal tract \< 0.5 cm. 8. Pregnancy, lactation or those with fertility but without contraceptive measures.
• \. 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.
• \. Patients with severe allergic history or specific constitution. 12. Researchers consider it inappropriate to participate in the test.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Weilin Wang, doctor

CONTACT

+86 0571 87783820; wam@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 27, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)