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Trial Title:
Preoperative Stereotactic Body Radiotherapy (SBRT) Followed by Hepatectomy for Centrally Located Hepatocellular Carcinoma: a Prospective, Single-center, Phase I Study
NCT ID:
NCT05598060
Condition:
Centrally Located Hepatocellular Carcinoma
Stereotactic Body Radiotherapy
Hepatectomy
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma.
Description:
Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by
hepatectomy for centrally located hepatocellular carcinoma.
Arm group label:
neoadjuvant stereotactic body radiation therapy followed by hepatectomy
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 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 (neo)adjuvant therapy before (or 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.
However, there are still lack of exploration for the efficacy of neoadjuvant SBRT. This
study is to analyze the safety of preoperative SBRT followed by hepatectomy for centrally
located hepatocellular carcinoma.
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. Centrally located hepatocellular carcinoma and medically fit to undergo surgery as
determined by the Multiple Disciplinary Team (MDT);
4. BCLC stage A
5. No imaging evidence of direct invasion of stomach, duodenum, small intestine, large
intestine or diaphragm of the intrahepatic lesions to be treated with radiotherapy;
6. Child-Pugh class A and B7;
7. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;
8. Willing to provide tissue from an excisional biopsy of a tumor lesion;
9. 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;
10. 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); 11. 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 local or systemic treatments in the past, including but not limited to
TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.;
2. Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
3. Extrahepatic metastasis;
4. Prior abdominal irradiation;
5. Any major surgery within 1 months prior to enrolment;
6. Known history of active Bacillus Tuberculosis (TB)
7. 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.
8. Active infection requiring systemic therapy;
9. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
form of immunosuppressive therapy;
10. Known psychiatric or substance abuse disorders ;
11. Pregnant or breastfeeding;
12. Known history of human immunodeficiency virus (HIV: HIV 1/2 antibodies);
13. 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 School of Medicine
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Recruiting
Contact:
Last name:
qichun wei, MD
Phone:
086-0571-87783521
Email:
qichun_wei@zju.edu.cn
Contact backup:
Last name:
yongjie shui, MM
Phone:
086-0571-87783521
Email:
syjhz@163.com
Start date:
November 1, 2022
Completion date:
February 1, 2024
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/NCT05598060
