Centrally Located Hepatocellular CarcinomaNCT05598060
Preoperative Stereotactic Body Radiotherapy (SBRT) Followed by Hepatectomy for Centrally Located Hepatocellular Carcinoma: a Prospective, Single-center, Phase I Study
A study testing Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma. in people with Centrally Located Hepatocellular Carcinoma and Stereotactic Body Radiotherapy, 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
- Centrally Located Hepatocellular Carcinoma, Stereotactic Body Radiotherapy, Hepatectomy
- What is being tested?
- Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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;
- Centrally located hepatocellular carcinoma and medically fit to undergo surgery as determined by the Multiple Disciplinary Team (MDT);
- BCLC stage A
- No imaging evidence of direct invasion of stomach, duodenum, small intestine, large intestine or diaphragm of the intrahepatic lesions to be treated with radiotherapy;
- Child-Pugh class A and B7;
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- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;
- Willing to provide tissue from an excisional biopsy of a tumor lesion;
- 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); 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.
Who cannot join
- Have received local or systemic treatments in the past, including but not limited to TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.;
- Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
- Extrahepatic metastasis;
- Prior abdominal irradiation;
- Any major surgery within 1 months prior to enrolment;
- Known history of active Bacillus Tuberculosis (TB)
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- 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;
- 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.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
qichun wei, MD, 086-0571-87783521, qichun_wei@zju.edu.cn
yongjie shui, MM, 086-0571-87783521, syjhz@163.com
About this 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 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.
- Being tested
- Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma.Radiation
Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant stereotactic body radiation therapy followed by hepatectomy | Experimental | Experimental: Phase1(Cohort 1): neoadjuvant stereotactic body radiation therapy (24Gy/3Fr) followed by hepatectomy Experimental: Phase1(Cohort 2): neoadjuvant stereotactic body radiation therapy (30Gy/3Fr) followed by hepatectomy Experimental: Phase1(Cohort 3): neoadjuvant stereotactic body radiation therapy (36Gy/3Fr) followed by hepatectomy Receives: Radiation: Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of radiotherapy followed by hepatectomy : Incidence of Treatment-Emergent Adverse events (CTCAE v5.0)
Safety and tolerability of radiotherapy followed by hepatectomy
Measured: 3 months after resection
Secondary outcomes (5)
Local recurrence free survival
Local recurrence free survival
Measured: from date of enrollment to date of first documented local recurrence. Assessed up to 12 months
Progression free survival
Progression free survival
Measured: from date of enrollment to the date of first documented progression. Assessed up to 12 months
Overall survival
Overall survival
Measured: from date of enrollment to the date of death from any cause. Assessed up to 12 months
Time to Progress
Time to Progress
Measured: from date of enrollment to the date of progress. Assessed up to 12 months
Quality of life by EORTC QLQ-C30
Quality of life by EORTC QLQ-C30
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Nov 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Centrally Located 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qichun Wei, MD/PhD, Study director, Zhejiang UniversityWeilin Wang, MD/PhD, Study director, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598060
- Sponsor's protocol ID
- 2022-0743
- Status last verified
- Sep 2022
- First submitted
- 18 Oct 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Stereotactic Body Radiotherapy (SBRT) Followed by Hepatectomy for Centrally Located Hepatocellular Carcinoma: a Prospective, Single-center, Phase I Study
- ClinicalTrials.gov ID
- NCT05598060
- Acronym / sponsor ID
- 2022-0743
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 28 Oct 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant stereotactic body radiation therapy followed by hepatectomy | Experimental | Radiation: Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma.Experimental: Phase1(Cohort 1): neoadjuvant stereotactic body radiation therapy (24Gy/3Fr) followed by hepatectomy Experimental: Phase1(Cohort 2): neoadjuvant stereotactic body radiation therapy (30Gy/3Fr) followed by hepatectomy Experimental: Phase1(Cohort 3): neoadjuvant stereotactic body radiation therapy (36Gy/3Fr) followed by hepatectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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;
- Centrally located hepatocellular carcinoma and medically fit to undergo surgery as determined by the Multiple Disciplinary Team (MDT);
- BCLC stage A
- No imaging evidence of direct invasion of stomach, duodenum, small intestine, large intestine or diaphragm of the intrahepatic lesions to be treated with radiotherapy;
Key exclusion criteria (13 listed)
- Have received local or systemic treatments in the past, including but not limited to TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.;
- Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
- Extrahepatic metastasis;
- Prior abdominal irradiation;
- Any major surgery within 1 months prior to enrolment;
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 |
|---|---|---|
| Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma.Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma. | Radiation | neoadjuvant stereotactic body radiation therapy followed by hepatectomy |
Primary outcome
Safety and tolerability of radiotherapy followed by hepatectomy : Incidence of Treatment-Emergent Adverse events (CTCAE v5.0)
Time frame: 3 months after resection
Safety and tolerability of radiotherapy followed by hepatectomy
5 secondary outcomes
Local recurrence free survival
Time frame: from date of enrollment to date of first documented local recurrence. Assessed up to 12 months
Progression free survival
Time frame: from date of enrollment to the date of first documented progression. Assessed up to 12 months
Overall survival
Time frame: from date of enrollment to the date of death from any cause. Assessed up to 12 months
Time to Progress
Time frame: from date of enrollment to the date of progress. Assessed up to 12 months
Quality of life by EORTC QLQ-C30
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
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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. This study is not recruiting at the moment.
Qichun Wei, MD/PhD study director
Zhejiang University
Weilin Wang, MD/PhD study director
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 Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma. in people with Centrally Located Hepatocellular Carcinoma and Stereotactic Body Radiotherapy, 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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qichun Wei, MD/PhD (187783521, qichun_wei@zju.deu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of radiotherapy followed by hepatectomy : Incidence of Treatment-Emergent Adverse events (CTCAE v5.0) (time frame: 3 months after resection). 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 6 Feb 2023.