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Trial Title:
Adjuvant Stereotactic Body Radiotherapy (SBRT) for Hepatocellular Carcinoma After Hepatectomy With Narrow Margin: a Prospective, Multi-center, Randomized Controlled, Open-labelled, Phase III Study
NCT ID:
NCT05602974
Condition:
Hepatocellular Carcinoma
Narrow Margin
Adjuvant Stereotactic Body Radiotherapy
Hepatectomy
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular carcinoma
Narrow margin
Adjuvant Stereotactic Body Radiotherapy
Hepatectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Experimental: adjuvant stereotactic body radiation therapy after hepatectomy with narrow
margin Control: regular follow-up after hepatectomy with narrow margin
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
stereotactic body radiation therapy
Description:
adjuvant stereotactic body radiation therapy
Arm group label:
adjuvant stereotactic body radiation therapy
Intervention type:
Other
Intervention name:
regular follow-up
Description:
regular follow-up
Arm group label:
regular follow-up
Summary:
Hepatocellular carcinoma (HCC) is the sixth prevalent malignancy worldwide. Although
surgical excision is considered the standard treatment for resectable HCC, a high rate of
postoperative recurrence was observed after partial hepatectomy, with a marginal
recurrence rate up to 30%. Narrow margin resection may be the most appropriate procedure
for centrally located HCC or HCC located near liver capsule because the premise for
survival is the conservation of more normal liver parenchyma. Unfortunately, narrow
margin resection has been reported to contribute to poor survival outcomes. However, no
adjuvant therapy after hepatectomy is generally considered to be effective in reducing
post-operative recurrence.
Radiotherapy (RT) has been well used in many solid malignant tumors as an (neo)adjuvant
to surgical treatment, including HCC. SBRT has shown encouraging rates of local control
for HCC. Compared with standard fractionation radiation, SBRT can achieve more precise
delivery of high-dose radiation beams to the lesion, obtaining a much smaller target
volume. Meanwhile, it could be finished in a short period which can bring more
convenience to patients. Recently, several study and randomized controlled trials
revealed the survival benefit of adjuvant RT (IMRT and SBRT) in patients with HCC. A
large-sample and high-quality multi-center, randomized controlled, prospective study is
warranted to further confirm the efficacy of adjuvant radiotherapy in patients with
narrow margin resection, considering the small sample size of above-mentioned studies.
Detailed description:
Hepatocellular carcinoma (HCC) is the sixth prevalent malignancy worldwide. Although
surgical excision is considered the standard treatment for resectable HCC, a high rate of
postoperative recurrence was observed after partial hepatectomy, with a marginal
recurrence rate up to 30%. Narrow margin resection may be the most appropriate procedure
for centrally located HCC or HCC located near liver capsule because the premise for
survival is the conservation of more normal liver parenchyma. Unfortunately, narrow
margin resection has been reported to contribute to poor survival outcomes. However, no
adjuvant therapy after hepatectomy is generally considered to be effective in reducing
post-operative recurrence.
Radiotherapy (RT) has been well used in many solid malignant tumors as an (neo)adjuvant
to surgical treatment, including HCC. SBRT has shown encouraging rates of local control
for HCC. Compared with standard fractionation radiation, SBRT can achieve more precise
delivery of high-dose radiation beams to the lesion, obtaining a much smaller target
volume. Meanwhile, it could be finished in a short period which can bring more
convenience to patients. Recently, several study and randomized controlled trials
revealed the survival benefit of adjuvant RT (IMRT and SBRT) in patients with HCC. A
large-sample and high-quality multi-center, randomized controlled, prospective study is
warranted to further confirm the efficacy of adjuvant radiotherapy in patients with
narrow margin resection, considering the small sample size of above-mentioned studies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged ≥18 years;
2. Confirmed diagnosis of HCC. The diagnosis can be established radiographically by the
criteria of the American Association for the Study of the Liver (AASLD), or by
histologic diagnosis from the core biopsy;
3. Pathologically confirmed as narrow margin (the shortest distance from the edge of
the tumor to the surface of liver transection <1cm) ;
4. Child-Pugh class A and B7;
5. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;
6. Willing to provide tissue from an excisional biopsy of a tumor lesion;
7. For patients with active HBV: HBV DNA < 2000 IU/mL during screening, and have
initiated anti-HBV treatment at least 7 days prior to SBRT and willingness to
continue anti-HBV treatment during the study;
8. Adequate organ and marrow function as defined below:
1)Marrow: absolute neutrophil count ≥1.5×109/L; platelets ≥50×109/L; hemoglobin ≥90g/L;
2)Liver: total bilirubin ≤3× institutional upper limit of normal (ULN); AST(aspartate
aminotransferase) or ALT(alanine aminotransferase) ≤ 5× institutional ULN; albumin
≥29g/L; 3)Kidney: creatinine ≤ 1.5× institutional ULN or estimated glomerular filtration
rate (GFR) ≥50 mL/min/1.73 m2 (according to the Cockcroft-Gault formula); 9. Women of
childbearing potential must be willing to use a highly effective method of contraception
for the course of the study through 30 days after radiotherapy. Female patient of
childbearing potential should have a negative serum pregnancy test before 72h of her
first treatment. Sexually active males must agree to use an adequate method of
contraception starting with the treatment through 4 months after radiotherapy.
Exclusion Criteria:
1. Have received radiotherapy for the area to be treated in the past;
2. Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
3. Extrahepatic metastasis;
4. Known history of active Bacillus Tuberculosis (TB)
5. Known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of
the skin that has undergone potentially curative therapy, or in situ cervical
cancer.
6. Active infection requiring systemic therapy;
7. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
form of immunosuppressive therapy;
8. Known psychiatric or substance abuse disorders ;
9. Pregnant or breastfeeding;
10. Known history of human immunodeficiency virus (HIV: HIV 1/2 antibodies);
11. Received a live vaccine within 30 days before radiotherapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the second affiliated hospital of Zhejiang University
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Start date:
March 1, 2023
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05602974
