Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The prognosis of small liver cancer (≤5 cm) with stereotactic body radiotherapy (SBRT) is encouraging, the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, and 3-year overall survival rate around 70%. So far, there is no randomized controlled study comparing SBRT and surgical treatment for early-stage liver cancer. It is hoped that this study will further compare the efficacy of SBRT and surgery for early stage liver cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05596630

Carcinoma; Hepatocellular

RECRUITING NA

Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

NCT01668134

Carcinoma, Hepatocellular Intrahepatic Cholangiocarcinoma

COMPLETED PHASE1

Comparison of Efficacy in SBRT of HCC ≤5 cm With or Without TACE

NCT04161287

Small Hepatocellular Carcinoma Stereotactic Body Radiation Therapy Transcatheter Arterial Chemoembolization

UNKNOWN

Preoperative Stereotactic Body Radiotherapy (SBRT) Followed by Hepatectomy for Centrally Located Hepatocellular Carcinoma: a Prospective, Single-center, Phase I Study

NCT05598060

Centrally Located Hepatocellular Carcinoma Stereotactic Body Radiotherapy Hepatectomy

UNKNOWN NA

Stereotactic Body Radiotherapy Versus Radiofrequency Ablation for Unresectable, Small (≤ 3 cm) HCC

NCT05433701

Hepatocellular Carcinoma

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Early stage liver cancer, according to Milan criteria, are chose for this study. The patients are divided into two groups randomly. Patients in group A receive laparoscopic hepatectomy, group B patients receive SBRT.The 3-year progression free survival, 3-year local recurrence free survival, 3- year overall survival and other endpoints events were recorded and analyzed, to assess whether SBRT is non-inferior to surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma Hepatectomy Stereotactic Body Radiotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group A

laparoscopic hepatectomy (surgery)

Group Type ACTIVE_COMPARATOR

laparoscopic hepatectomy (surgery)

Intervention Type PROCEDURE

Patients receive laparoscopic hepatectomy.

group B

stereotactic body radiotherapy (SBRT)

Group Type EXPERIMENTAL

stereotactic body radiotherapy

Intervention Type RADIATION

Patients receive stereotactic body radiotherapy(SBRT)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

laparoscopic hepatectomy (surgery)

Patients receive laparoscopic hepatectomy.

Intervention Type PROCEDURE

stereotactic body radiotherapy

Patients receive stereotactic body radiotherapy(SBRT)

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 18 years old and above.
2. Clinical or pathological diagnosis of hepatocellular carcinoma, initial treatment (without surgery, radiotherapy, chemotherapy or targeted therapy).
3. Early-stage hepatocellular carcinoma meeting the Milan criteria: single lesion ≤ 5cm, or tumor number ≤ 3, maximum diameter ≤ 3cm, no major vascular invasion of portal vein, hepatic vein, inferior vena cava, no bile duct invasion, no lymph node and extrahepatic metastasis.
4. No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency.
5. The neutrophil count is at least 1.0\*10\^9/ml, and the platelet count is at least 50\*10\^9/ml. Hemoglobin is at least 80g/L.
6. Men or women with fertility are willing to take contraceptive measures during the trial.
7. Eastern Cooperative Oncology Group score 0-1 points.
8. Expected survival period \> 3 months.
9. Voluntary participation and signing of informed consent.

Exclusion Criteria

1. Patients who have undergone chemoradiation or targeted therapy for liver cancer.
2. Recent hematemesis due to portal hypertension.
3. Child-Pugh score ≥10 points.
4. Total bilirubin\>70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times.
5. who was considered unsuitable for surgery after hepatobiliary and pancreas multidisciplinary treatment（MDT） meeting.
6. Patients undergoing major surgery within 1 month of study initiation
7. 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)
8. Researchers consider it inappropriate to participate in the test

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No