Carcinoma, HepatocellularNCT02580929
Clinical Study of Effectiveness of Radiotherapy Before Surgery in High-risk Relapse Hepatocellular Cancer Patients
A study testing radiotherapy in people with Carcinoma, Hepatocellular, run by Peking Union Medical College at 1 site in China.
Trial summary
This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk relapse hepatocellular cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Jul 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of HCC
- In high risk of recurrence of HCC but still can endure palliative resection
- KPS scores are >90
- With Child-Pugh Class A liver funcion, serum bilirubin< 1.5*normal maxism; ALT and AST< 1.5*normal maxism; normal creatinine and urea nitrogen; WBC>4×109/L, Hb>110g/L, PLT>90X109/L.
- Have signed informed consent
Who cannot join
- HCC cannot be operated
- With Child-Pugh Class B/C
- Have other organ cancer, excluding curative non-melanotic skin cancer and carcinoma in situ of cervix
- Have other severe disease
- With active hepatitis
- Have accepted local radiation therapy in other hospitals
Show all 13Show fewer
- KPS scores≤70
- Tumor edges cannot be defined
- Have severe cirrhosis complication
- Intensity modulated radiation therapy cannot reach required dose
- Cannot cooperate
- Lactant or pregnant
- Cannnot be informed
Trial locations and contacts
1 site in 1 country.
FAN WU contact
About this study
Official title: Effectiveness of Radiotherapy Before Surgery in Patients With High-risk Relapse Hepatocellular Carcinoma
This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk relapse hepatocellular cancer patients.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- radiotherapy
- Keywords
- Radiotherapy, General Surgery
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
radiotherapy before surgery
| Study group | Role | What they receive |
|---|---|---|
| radiation | Experimental | Not described Receives: Radiation: radiotherapy |
| no radiation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hope Run
- Responsible party
- Principal investigator, WU FAN, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580929
- Sponsor's protocol ID
- LC2014B10
- Status last verified
- Oct 2015
- First submitted
- 10 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu F, Chen B, Dong D, Rong W, Wang H, Wang L, Wang S, Jin J, Song Y, Liu Y, Fang H, Tang Y, Li N, Zhu X, Li Y, Wang W, Wu J. Phase 2 Evaluation of Neoadjuvant Intensity-Modulated Radiotherapy in Centrally Located Hepatocellular Carcinoma: A Nonrandomized Controlled Trial. JAMA Surg. 2022 Dec 1;157(12):1089-1096. doi: 10.1001/jamasurg.2022.4702.
PubMed 36197682
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Radiotherapy Before Surgery in Patients With High-risk Relapse Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02580929
- Acronym / sponsor ID
- LC2014B10
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Radiotherapy, General Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Collaborators
- Beijing Hope Run
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 20 Oct 2015 (estimated)
- 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.
This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk relapse hepatocellular cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiation | Experimental | Radiation: radiotherapy |
| no radiation | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of HCC
- In high risk of recurrence of HCC but still can endure palliative resection
- KPS scores are >90
- With Child-Pugh Class A liver funcion, serum bilirubin< 1.5*normal maxism; ALT and AST< 1.5*normal maxism; normal creatinine and urea nitrogen; WBC>4×109/L, Hb>110g/L, PLT>90X109/L.
- Have signed informed consent
Key exclusion criteria (13 listed)
- HCC cannot be operated
- With Child-Pugh Class B/C
- Have other organ cancer, excluding curative non-melanotic skin cancer and carcinoma in situ of cervix
- Have other severe disease
- With active hepatitis
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 |
|---|---|---|
| radiotherapyradiotherapy before surgery | Radiation | radiation |
Primary outcome
mortality
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
- Derived from this study: PubMed 36197682Wu F, Chen B, Dong D, Rong W, Wang H, Wang L, Wang S, Jin J, Song Y, Liu Y, Fang H, Tang Y, Li N, Zhu X, Li Y, Wang W, Wu J. Phase 2 Evaluation of Neoadjuvant Intensity-Modulated Radiotherapy in Centrally Located Hepatocellular Carcinoma: A Nonrandomized Controlled Trial. JAMA Surg. 2022 Dec 1;157(12):1089-1096. doi: 10.1001/jamasurg.2022.4702.
Related trials for Carcinoma, Hepatocellular
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
FAN WU contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiotherapy in people with Carcinoma, Hepatocellular, run by Peking Union Medical College 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 5 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 22 Oct 2015. 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 FAN WU (wufan1011@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580929, which also lists 1 linked publication.
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 22 Oct 2015.