Hepatocellular CarcinomaRAISENCT03732105
Randomized Study of Adjuvant Radiotherapy After Curative Resection of HCC With Narrow Margin (RAISE)
A study testing Surgery-radiotherapy in people with Hepatocellular Carcinoma and Radiotherapy, run by Sun Yat-sen University at 1 site in China.
Trial summary
RAISE is a multicenter randomized controlled trial to assess the efficacy of adjuvant radiotherapy for controlling postsurgical recurrence in HCC patients with narrow margin (≤ 1 cm) after curative resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Radiotherapy, Hepatectomy
- What is being tested?
- Surgery-radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2018to 11 Aug 2025
- 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
- Age 18 - 75 years.
- HCC who underwent R0 resection with pathological confirmation.
- The narrowest margin is less than or equal to 1 cm.
- No residual tumors after surgery based on postoperative CT or MR images in 4-6 weeks.
- ECOG PS ≤ 1.
- Child-Pugh score 5-7.
- Expected life expectancy ≥ 6 months.
- Blood, liver, and kidney functions meet the following criteria: 1)Neutrophil counts ≥ 1.5×109/L; 2)Platelet counts ≥ 60×109/L; 3)Hemoglobin concentration ≥ 90g/L; 4)Serum albumin concentration ≥ 30g/L; 5)Bilirubin ≤ 1.5 × upper limit of normal; 6)AST and ALT < 3× ULN; 7)Extended prothrombin time not exceeding 3s of ULN; 8)Creatinine < 1.5× ULN.
Who cannot join
- Preoperative imaging revealed tumor thrombus in the portal vein, hepatic vein, bile duct, or extrahepatic metastasis.
- The number of tumors ≥4.
- Pregnant or lactating women or subjects scheduled for contraceptive procedures within 2 years.
- Patients with concomitant HIV or syphilis infection.
- Patients with concurrent or other malignancies within 5 years before enrollment.
- Patients receiving allogeneic organ transplantation.
- Patients with severe dysfunction of the heart, kidneys or other organs.
- Participated in clinical trials of other drugs within 12 months before enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Ming Kuang, Ph.D., 008687755766 ext. 8576, kuangm@mail.sysu.edu.cn
About this study
Official title: Randomized Study of Adjuvant Radiotherapy After Curative Resection of Hepatocellular Carcinoma With Narrow Margin (≤1 cm)
RAISE is a multicenter randomized controlled trial to assess the efficacy of adjuvant radiotherapy for controlling postsurgical recurrence in HCC patients with narrow margin (≤ 1 cm) after curative resection.
Read the detailed description
RAISE trial will recruit 148 patients, and they will be randomized (1:1) to two groups (the surgery group and the surgery-radiotherapy group). Random assignment was stratified by the condition of MVI and tumor size. All patients in the surgery-radiotherapy group received Intensity Modulated Radiation Therapy (IMRT) within 1-3 months after surgical resection. The prescription dose was planned at 50 gray in 25 fractions over 5-6 weeks. The trial is to verify whether adjuvant radiotherapy prolongs recurrence-free survival in patients with a narrow resection margin.
- Conditions
- Hepatocellular Carcinoma, Radiotherapy, Hepatectomy
- Being tested
- Surgery-radiotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery-radiotherapyRadiation
Patients in the surgery-radiotherapy group will receive Intensity Modulated Radiation Therapy (IMRT) at a dose of 50Gy/25fraction after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Surgery-radiotherapy | Experimental | Patients in the surgery-radiotherapy group will receive Intensity Modulated Radiation Therapy (IMRT) at a dose of 50Gy/25fraction after surgery. After radiotherapy, patients will be actively monitored. Receives: Radiation: Surgery-radiotherapy |
| Surgery group | No intervention | Patients in the surgery group will be actively monitored after randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival,RFS
Defined as the time from randomization until disease recurrence or death from any cause, whichever happens first.
Measured: two years
Secondary outcomes (4)
Overall Survival, OS
Defined as the time from randomization until death from any cause.
Measured: two years
Time To Recurrence, TTR
Defined as the time from randomization until disease recurrence.
Measured: two years
Incidence of Treatment-Emergent Adverse Events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4).
Incidence of Treatment-Emergent Adverse Events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4)causality of Adverse Events (AEs) during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4).
Measured: two years
health related quality of life
The quality of life is accessed by EORTC QLQ-C30 (version 3).
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start8 Aug 2018
- Primary completion11 Aug 2025 (estimated)
- Study completion11 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Medical University, Southern Medical University, China, Shantou University Medical College
- Responsible party
- Principal investigator, Ming Kuang, Sun Yat-sen University
- Investigators
- Ming Kuang, PhD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732105
- Sponsor's protocol ID
- 2018175
- Acronym
- RAISE
- Status last verified
- Apr 2024
- First submitted
- 4 Nov 2018
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rodriguez-Peralvarez M, Luong TV, Andreana L, Meyer T, Dhillon AP, Burroughs AK. A systematic review of microvascular invasion in hepatocellular carcinoma: diagnostic and prognostic variability. Ann Surg Oncol. 2013 Jan;20(1):325-39. doi: 10.1245/s10434-012-2513-1. Epub 2012 Nov 13.
PubMed 23149850Wang WH, Wang Z, Wu JX, Zhang T, Rong WQ, Wang LM, Jin J, Wang SL, Song YW, Liu YP, Ren H, Fang H, Wang WQ, Liu XF, Yu ZH, Li YX. Survival benefit with IMRT following narrow-margin hepatectomy in patients with hepatocellular carcinoma close to major vessels. Liver Int. 2015 Dec;35(12):2603-10. doi: 10.1111/liv.12857. Epub 2015 Jun 3.
PubMed 25939444Yu W, Wang W, Rong W, Wang L, Xu Q, Wu F, Liu L, Wu J. Adjuvant radiotherapy in centrally located hepatocellular carcinomas after hepatectomy with narrow margin (<1 cm): a prospective randomized study. J Am Coll Surg. 2014 Mar;218(3):381-92. doi: 10.1016/j.jamcollsurg.2013.11.030. Epub 2013 Dec 2.
PubMed 24559953
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Adjuvant Radiotherapy After Curative Resection of Hepatocellular Carcinoma With Narrow Margin (≤1 cm)
- ClinicalTrials.gov ID
- NCT03732105
- Acronym / sponsor ID
- RAISE / 2018175
- Conditions
- Hepatocellular Carcinoma, Radiotherapy, Hepatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Medical University, Southern Medical University, China, Shantou University Medical College
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 11 Aug 2025 (estimated)
- Study completion
- 11 Aug 2025 (estimated)
- First posted
- 6 Nov 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.
RAISE is a multicenter randomized controlled trial to assess the efficacy of adjuvant radiotherapy for controlling postsurgical recurrence in HCC patients with narrow margin (≤ 1 cm) after curative resection.
Detailed description
RAISE trial will recruit 148 patients, and they will be randomized (1:1) to two groups (the surgery group and the surgery-radiotherapy group). Random assignment was stratified by the condition of MVI and tumor size. All patients in the surgery-radiotherapy group received Intensity Modulated Radiation Therapy (IMRT) within 1-3 months after surgical resection. The prescription dose was planned at 50 gray in 25 fractions over 5-6 weeks. The trial is to verify whether adjuvant radiotherapy prolongs recurrence-free survival in patients with a narrow resection margin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery-radiotherapy | Experimental | Radiation: Surgery-radiotherapyPatients in the surgery-radiotherapy group will receive Intensity Modulated Radiation Therapy (IMRT) at a dose of 50Gy/25fraction after surgery. After radiotherapy, patients will be actively monitored. |
| Surgery group | No intervention | –Patients in the surgery group will be actively monitored after randomization. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 - 75 years.
- HCC who underwent R0 resection with pathological confirmation.
- The narrowest margin is less than or equal to 1 cm.
- No residual tumors after surgery based on postoperative CT or MR images in 4-6 weeks.
- ECOG PS ≤ 1.
Key exclusion criteria (8 listed)
- Preoperative imaging revealed tumor thrombus in the portal vein, hepatic vein, bile duct, or extrahepatic metastasis.
- The number of tumors ≥4.
- Pregnant or lactating women or subjects scheduled for contraceptive procedures within 2 years.
- Patients with concomitant HIV or syphilis infection.
- Patients with concurrent or other malignancies within 5 years before enrollment.
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 |
|---|---|---|
| Surgery-radiotherapyPatients in the surgery-radiotherapy group will receive Intensity Modulated Radiation Therapy (IMRT) at a dose of 50Gy/25fraction after randomization. | Radiation | Surgery-radiotherapy |
Primary outcome
Recurrence Free Survival,RFS
Time frame: two years
Defined as the time from randomization until disease recurrence or death from any cause, whichever happens first.
4 secondary outcomes
Overall Survival, OS
Time frame: two years
Time To Recurrence, TTR
Time frame: two years
Incidence of Treatment-Emergent Adverse Events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4).
Time frame: two years
health related quality of life
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Results publication: PubMed 23149850Rodriguez-Peralvarez M, Luong TV, Andreana L, Meyer T, Dhillon AP, Burroughs AK. A systematic review of microvascular invasion in hepatocellular carcinoma: diagnostic and prognostic variability. Ann Surg Oncol. 2013 Jan;20(1):325-39. doi: 10.1245/s10434-012-2513-1. Epub 2012 Nov 13.
- Results publication: PubMed 25939444Wang WH, Wang Z, Wu JX, Zhang T, Rong WQ, Wang LM, Jin J, Wang SL, Song YW, Liu YP, Ren H, Fang H, Wang WQ, Liu XF, Yu ZH, Li YX. Survival benefit with IMRT following narrow-margin hepatectomy in patients with hepatocellular carcinoma close to major vessels. Liver Int. 2015 Dec;35(12):2603-10. doi: 10.1111/liv.12857. Epub 2015 Jun 3.
- Results publication: PubMed 24559953Yu W, Wang W, Rong W, Wang L, Xu Q, Wu F, Liu L, Wu J. Adjuvant radiotherapy in centrally located hepatocellular carcinomas after hepatectomy with narrow margin (<1 cm): a prospective randomized study. J Am Coll Surg. 2014 Mar;218(3):381-92. doi: 10.1016/j.jamcollsurg.2013.11.030. Epub 2013 Dec 2.
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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.
Ming Kuang, PhD principal investigator
First Affiliated Hospital, Sun Yat-Sen 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 Surgery-radiotherapy in people with Hepatocellular Carcinoma and Radiotherapy, run by Sun Yat-sen University 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 8 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 18 Apr 2024. 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 Ming Kuang, PhD (008687755766 ext. 8576, kuangm@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Free Survival,RFS (time frame: two 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 NCT03732105, which also lists 3 linked publications.
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 18 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.