Hepatocellular CarcinomaNCT03609151
Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma
A study testing laparoscopic hepatectomy (surgery) and stereotactic body radiotherapy in people with Hepatocellular Carcinoma and Hepatectomy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatectomy, Stereotactic Body Radiotherapy
- What is being tested?
- laparoscopic hepatectomy (surgery) and stereotactic body radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2018to 31 May 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and above.
- Clinical or pathological diagnosis of hepatocellular carcinoma, initial treatment (without surgery, radiotherapy, chemotherapy or targeted therapy).
- 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.
- No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency.
- 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.
- Men or women with fertility are willing to take contraceptive measures during the trial.
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- Eastern Cooperative Oncology Group score 0-1 points.
- Expected survival period > 3 months.
- Voluntary participation and signing of informed consent.
Who cannot join
- Patients who have undergone chemoradiation or targeted therapy for liver cancer.
- Recent hematemesis due to portal hypertension.
- Child-Pugh score ≥10 points.
- Total bilirubin>70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times.
- who was considered unsuitable for surgery after hepatobiliary and pancreas multidisciplinary treatment（MDT） meeting.
- Patients undergoing major surgery within 1 month of study initiation
- 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)
- Researchers consider it inappropriate to participate in the test
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
Qichun Wei, MD,PhD, +86 571 87783521, qichun_wei@zju.edu.cn
Yongjie Shui, MM, +86 571 87783521, shui-yongjie@zju.edu.cn
About this study
Official title: Effects of Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma: a Prospective,Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- laparoscopic hepatectomy (surgery), stereotactic body radiotherapy
- Keywords
- Hepatocellular carcinoma, Early-stage liver cancer, Hepatectomy, Stereotactic body radiotherapy
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic hepatectomy (surgery)Procedure or surgery
Patients receive laparoscopic hepatectomy.
stereotactic body radiotherapyRadiation
Patients receive stereotactic body radiotherapy(SBRT)
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | laparoscopic hepatectomy (surgery) Receives: Procedure: laparoscopic hepatectomy (surgery) |
| group B | Experimental | stereotactic body radiotherapy (SBRT) Receives: Radiation: stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
The duration (months) between the date of surgery or the first fraction of SBRT until the date of first progression
Measured: From the date of surgery or the first fraction of SBRT until the date of first progression (local or distant), assessed up to 3 years
Secondary outcomes (2)
Local recurrence free survival
The duration (months) between the date of surgery or the first fraction of SBRT until the date of local recurrence
Measured: From the date of surgery or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years
Overall survival
The duration (months) between the date of surgery or the first fraction of SBRT until the date of death.
Measured: From the date of surgery or the first fraction of SBRT until the date of death, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start30 Jun 2018
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (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
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609151
- Sponsor's protocol ID
- IR2018001024
- Status last verified
- Jul 2018
- First submitted
- 2 Jul 2018
- Last updated
- 1 Aug 2018
- 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 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma: a Prospective,Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03609151
- Acronym / sponsor ID
- IR2018001024
- Keywords
- Hepatocellular carcinoma, Early-stage liver cancer, Hepatectomy, Stereotactic body radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 1 Aug 2018 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: laparoscopic hepatectomy (surgery)laparoscopic hepatectomy (surgery) |
| group B | Experimental | Radiation: stereotactic body radiotherapystereotactic body radiotherapy (SBRT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years old and above.
- Clinical or pathological diagnosis of hepatocellular carcinoma, initial treatment (without surgery, radiotherapy, chemotherapy or targeted therapy).
- 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.
- No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency.
- 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.
Key exclusion criteria (8 listed)
- Patients who have undergone chemoradiation or targeted therapy for liver cancer.
- Recent hematemesis due to portal hypertension.
- Child-Pugh score ≥10 points.
- Total bilirubin>70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times.
- who was considered unsuitable for surgery after hepatobiliary and pancreas multidisciplinary treatment（MDT） meeting.
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 |
|---|---|---|
| laparoscopic hepatectomy (surgery)Patients receive laparoscopic hepatectomy. | Procedure or surgery | group A |
| stereotactic body radiotherapyPatients receive stereotactic body radiotherapy(SBRT) | Radiation | group B |
Primary outcome
Progression free survival
Time frame: From the date of surgery or the first fraction of SBRT until the date of first progression (local or distant), assessed up to 3 years
The duration (months) between the date of surgery or the first fraction of SBRT until the date of first progression
2 secondary outcomes
Local recurrence free survival
Time frame: From the date of surgery or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years
Overall survival
Time frame: From the date of surgery or the first fraction of SBRT until the date of death, assessed up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic hepatectomy (surgery) and stereotactic body radiotherapy in people with Hepatocellular Carcinoma and Hepatectomy, 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 8 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 1 Aug 2018. 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 (+86 571 87783521, qichun_wei@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From the date of surgery or the first fraction of SBRT until the date of first progression (local or distant), assessed up to 3 years). 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 1 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.