Hepatocellular CarcinomaNCT05602974
Adjuvant Stereotactic Body Radiotherapy (SBRT) for Hepatocellular Carcinoma After Hepatectomy With Narrow Margin: a Prospective, Multi-center, Randomized Controlled, Open-labelled, Phase III Study
A study testing stereotactic body radiation therapy and regular follow-up in people with Hepatocellular Carcinoma and Narrow Margin, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Narrow Margin, Adjuvant Stereotactic Body Radiotherapy
- What is being tested?
- stereotactic body radiation therapy and regular follow-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years;
- 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;
- Pathologically confirmed as narrow margin (the shortest distance from the edge of the tumor to the surface of liver transection <1cm) ;
- Child-Pugh class A and B7;
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;
- Willing to provide tissue from an excisional biopsy of a tumor lesion;
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- 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;
- 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.
Who cannot join
- Have received radiotherapy for the area to be treated in the past;
- Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
- Extrahepatic metastasis;
- Known history of active Bacillus Tuberculosis (TB)
- 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.
- Active infection requiring systemic therapy;
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- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy;
- Known psychiatric or substance abuse disorders ;
- Pregnant or breastfeeding;
- Known history of human immunodeficiency virus (HIV: HIV 1/2 antibodies);
- Received a live vaccine within 30 days before radiotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: Adjuvant Stereotactic Body Radiotherapy (SBRT) for Hepatocellular Carcinoma After Hepatectomy With Narrow Margin: a Prospective, Multicenter, Randomized Controlled, Open-labelled, Phase III Study
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Narrow Margin, Adjuvant Stereotactic Body Radiotherapy, Hepatectomy
- Being tested
- stereotactic body radiation therapy, regular follow-up
- Keywords
- Hepatocellular carcinoma, Narrow margin, Adjuvant Stereotactic Body Radiotherapy, Hepatectomy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiation therapyRadiation
adjuvant stereotactic body radiation therapy
regular follow-upOther
regular follow-up
| Study group | Role | What they receive |
|---|---|---|
| adjuvant stereotactic body radiation therapy | Experimental | adjuvant stereotactic body radiation therapy after hepatectomy with narrow margin Receives: Radiation: stereotactic body radiation therapy |
| regular follow-up | Active comparator | regular follow-up after hepatectomy with narrow margin Receives: Other: regular follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal recurrence rate
1-year marginal recurrence rate
Measured: from date of enrollment to date of first documented marginal recurrence. Assessed up to 12 months
Secondary outcomes (5)
Overall survival
3-year Overall survival
Measured: from date of enrollment to the date of death from any cause. Assessed up to 36 months
Recurrence free survival
3-year Recurrence free survival
Measured: from date of enrollment to the date of first documented recurrence. Assessed up to 36 months
Time to Progress
from date of enrollment to the date of progress. Assessed up to 36 months
Measured: from date of enrollment to the date of progress. Assessed up to 36 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse events (CTCAE v5.0)
Measured: 6 months after SBRT
Quality of life by EORTC QLQ-C30
Quality of life by EORTC QLQ-C30
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Mar 2023 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: adjuvant stereotactic body radiation therapy after hepatectomy with narrow margin Control: regular follow-up after hepatectomy with narrow margin
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qichun Wei, MD/PhD, Principal investigator, Zhejiang UniversityWeilin Wang, MD/PhD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602974
- Sponsor's protocol ID
- 2022-0908
- Status last verified
- Oct 2022
- First submitted
- 29 Oct 2022
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Stereotactic Body Radiotherapy (SBRT) for Hepatocellular Carcinoma After Hepatectomy With Narrow Margin: a Prospective, Multicenter, Randomized Controlled, Open-labelled, Phase III Study
- ClinicalTrials.gov ID
- NCT05602974
- Acronym / sponsor ID
- 2022-0908
- Conditions
- Hepatocellular Carcinoma, Narrow Margin, Adjuvant Stereotactic Body Radiotherapy, Hepatectomy
- Keywords
- Hepatocellular carcinoma, Narrow margin, Adjuvant Stereotactic Body Radiotherapy, Hepatectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental: adjuvant stereotactic body radiation therapy after hepatectomy with narrow margin Control: regular follow-up after hepatectomy with narrow margin
| Arm | Type | Receives |
|---|---|---|
| adjuvant stereotactic body radiation therapy | Experimental | Radiation: stereotactic body radiation therapyadjuvant stereotactic body radiation therapy after hepatectomy with narrow margin |
| regular follow-up | Active comparator | Other: regular follow-upregular follow-up after hepatectomy with narrow margin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged ≥18 years;
- 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;
- Pathologically confirmed as narrow margin (the shortest distance from the edge of the tumor to the surface of liver transection <1cm) ;
- Child-Pugh class A and B7;
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;
Key exclusion criteria (11 listed)
- Have received radiotherapy for the area to be treated in the past;
- Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
- Extrahepatic metastasis;
- Known history of active Bacillus Tuberculosis (TB)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic body radiation therapyadjuvant stereotactic body radiation therapy | Radiation | adjuvant stereotactic body radiation therapy |
| regular follow-upregular follow-up | Other | regular follow-up |
Primary outcome
marginal recurrence rate
Time frame: from date of enrollment to date of first documented marginal recurrence. Assessed up to 12 months
1-year marginal recurrence rate
5 secondary outcomes
Overall survival
Time frame: from date of enrollment to the date of death from any cause. Assessed up to 36 months
Recurrence free survival
Time frame: from date of enrollment to the date of first documented recurrence. Assessed up to 36 months
Time to Progress
Time frame: from date of enrollment to the date of progress. Assessed up to 36 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 6 months after SBRT
Quality of life by EORTC QLQ-C30
Time frame: through study completion, an average of 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qichun Wei, MD/PhD principal investigator
Zhejiang University
Weilin Wang, MD/PhD principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic body radiation therapy and regular follow-up in people with Hepatocellular Carcinoma and Narrow Margin, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongjie Shui, MM (+8657187783521, shui-yongjie@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal recurrence rate (time frame: from date of enrollment to date of first documented marginal recurrence. Assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.