HepatoCellular CarcinomaRHCC:BCLC-ANCT02678806
Radiotherapy in Hepatocellular Carcinomas After Hepatectomy With Narrow Margin (<1 cm) and / or Microvascular Invasion
A study testing Postoperative radiotherapy and Postoperative TACE in people with HepatoCellular Carcinoma, run by Guangxi Medical University at 1 site in China.
Trial summary
Hepatocellular carcinoma is one of ten leading cancer types worldwide and also in Asia, but the five-year relative survival rate is relatively quite low1-3. For hepatocellular carcinoma treatment, current options are surgical resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HepatoCellular Carcinoma
- What is being tested?
- Postoperative radiotherapy and Postoperative TACE
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 1 Nov 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients were pathologically diagnosed as BCLC-A stage hepatocellular carcinomas, liver function were Child-Pugh class A or liver function changed from class B to class A after short-term liver treatment, PS scored 0-1, and accepted hepatocellular carcinomas resection (R0 resection).
- No recurrence was found within 3-4 weeks after surgery.
- pathologically confirmed as narrow margin (the closest distance from margin to tumor capsule (<1 cm) and microvascular invasion was found in tumor capsule and adjacent tissues junction (material selection and pathological diagnosis were based on "Standardization pathology Guide of primary liver cancer 2015 edition" ).
- Postoperative radiotherapy was the only combination therapy within one month after surgery.
- Radiation range was margin radiation along and/or joint portal vessels radiotherapy.
- No lymph node and distant metastasis before surgery.
Who cannot join
- Patients were pathologically diagnosed as BCLC-B, C, D stage hepatocellular carcinomas, liver function were Child-Pugh class C, PS scored ≥2. Or primary liver cancer patients were pathologically diagnosed as cholangiocarcinoma or mixed type liver cancer. Or patients did not accept hepatectomy.
- Patients received transcatheter arterial chemoembolization, chemotherapy, targeted medicine or other anti-cancer therapy before surgery.
- Recurrence was found within 3-4 weeks after surgery.
- Postoperative adjuvant therapy included treatment other than radiotherapy within one month after surgery.
- Radiation range involved lymph node other than portal vein area.
- Lymph node and distant metastasis were diagnosed before surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
TaoBai
Nanning, Guangxi, 530000
Bai Tao, MD, +86 13878862632, 25859373@qq.com
About this study
Hepatocellular carcinoma is one of ten leading cancer types worldwide and also in Asia, but the five-year relative survival rate is relatively quite low1-3. For hepatocellular carcinoma treatment, current options are surgical resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene therapy, etc. Among them, the use of radiation therapy is getting more and more attention, and it is changing from the past palliative treatment to current curable treatment. From an oncologic point of view, a narrow margin <1 cm and microvascular invasion is not safe and is often associated with higher rates of recurrence and shorter patient survival.On the other hand, it is also believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the resection margin. To address this issue, the investigators are going to conduct a series of retrospective and prospective studies to investigate the effect of adjuvant Radiotherapy for centrally located hepatocellular carcinoma after narrow margin (<1 cm) hepatectomy on tumor recurrence.
- Conditions
- HepatoCellular Carcinoma
- Being tested
- Postoperative radiotherapy, Postoperative TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative radiotherapyRadiation
The radiotherapy group received prophylactic radiotherapy 1 month after operation. All the patients in the experimental group were treated with 6 to 8 MV X-ray, intensity-modulated irradiation (IMRT) technique, which was divided into 4-5 fields, 2Gy/25 times. 5f/W, total dose 50Gy
Postoperative TACEDrug
In the intervention group, TACE was performed in January and March after operation. The femoral artery puncture was performed by Seldinger method, and the cannula was intubated to the hepatic artery by DSA. Then, 50 mg of lobaplatin plus 4 mg of raltitrexed was injected into the vascular artery. The embolic agent was selected as 38.0. % super liquefied iodine solution and / or gelatin sponge particles, the dose is maintained at 5 ~ 20ml. At the end of treatment, a DSA examination again confirmed that the tumor was completely occluded.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative radiotherapy group | Experimental | Patients hospitalized in Affiliated Tumor Hospital of Guangxi Medical University from 1st November 2017, who were diagnosed as BCLC-A stage hepatocellular carcinoma, accepted hepatocellular carcinoma resection, pathologically confirmed as narrow margin (the closest distance from margin to tumor capsule < 1cm) and microvascular invasion was found in tumor capsule and adjacent tissues junction were selected and received margin postoperative radiotherapy. Receives: Radiation: Postoperative radiotherapy |
| Postoperative TACE group | Active comparator | Not described Receives: Drug: Postoperative TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study start1 Nov 2017
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Nov 2022 (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.
- 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
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TaoBai, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678806
- Sponsor's protocol ID
- GDWTaoBai
- Acronym
- RHCC:BCLC-A
- Status last verified
- Jul 2018
- First submitted
- 23 Jan 2016
- Last updated
- 10 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy in Hepatocellular Carcinomas After Hepatectomy With Narrow Margin (<1 cm) and / or Microvascular Invasion
- ClinicalTrials.gov ID
- NCT02678806
- Acronym / sponsor ID
- RHCC:BCLC-A / GDWTaoBai
- Conditions
- HepatoCellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 10 Feb 2016 (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.
Hepatocellular carcinoma is one of ten leading cancer types worldwide and also in Asia, but the five-year relative survival rate is relatively quite low1-3. For hepatocellular carcinoma treatment, current options are surgical resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene therapy, etc. Among them, the use of radiation therapy is getting more and more attention, and it is changing from the past palliative treatment to current curable treatment. From an oncologic point of view, a narrow margin <1 cm and microvascular invasion is not safe and is often associated with higher rates of recurrence and shorter patient survival.On the other hand, it is also believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the resection margin. To address this issue, the investigators are going to conduct a series of retrospective and prospective studies to investigate the effect of adjuvant Radiotherapy for centrally located hepatocellular carcinoma after narrow margin (<1 cm) hepatectomy on tumor recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative radiotherapy group | Experimental | Radiation: Postoperative radiotherapyPatients hospitalized in Affiliated Tumor Hospital of Guangxi Medical University from 1st November 2017, who were diagnosed as BCLC-A stage hepatocellular carcinoma, accepted hepatocellular carcinoma resection, pathologically confirmed as narrow margin (the closest distance from margin to tumor capsule < 1cm) and microvascular invasion was found in tumor capsule and adjacent tissues junction were selected and received margin postoperative radiotherapy. |
| Postoperative TACE group | Active comparator | Drug: Postoperative TACE |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients were pathologically diagnosed as BCLC-A stage hepatocellular carcinomas, liver function were Child-Pugh class A or liver function changed from class B to class A after short-term liver treatment, PS scored 0-1, and accepted hepatocellular carcinomas resection (R0 resection).
- No recurrence was found within 3-4 weeks after surgery.
- pathologically confirmed as narrow margin (the closest distance from margin to tumor capsule (<1 cm) and microvascular invasion was found in tumor capsule and adjacent tissues junction (material selection and pathological diagnosis were based on "Standardization pathology Guide of primary liver cancer 2015 edition" ).
- Postoperative radiotherapy was the only combination therapy within one month after surgery.
- Radiation range was margin radiation along and/or joint portal vessels radiotherapy.
Key exclusion criteria (6 listed)
- Patients were pathologically diagnosed as BCLC-B, C, D stage hepatocellular carcinomas, liver function were Child-Pugh class C, PS scored ≥2. Or primary liver cancer patients were pathologically diagnosed as cholangiocarcinoma or mixed type liver cancer. Or patients did not accept hepatectomy.
- Patients received transcatheter arterial chemoembolization, chemotherapy, targeted medicine or other anti-cancer therapy before surgery.
- Recurrence was found within 3-4 weeks after surgery.
- Postoperative adjuvant therapy included treatment other than radiotherapy within one month after surgery.
- Radiation range involved lymph node other than portal vein area.
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 |
|---|---|---|
| Postoperative radiotherapyThe radiotherapy group received prophylactic radiotherapy 1 month after operation. All the patients in the experimental group were treated with 6 to 8 MV X-ray, intensity-modulated irradiation (IMRT) technique, which was divided into 4-5 fields, 2Gy/25 times. 5f/W, total dose 50Gy | Radiation | Postoperative radiotherapy group |
| Postoperative TACEIn the intervention group, TACE was performed in January and March after operation. The femoral artery puncture was performed by Seldinger method, and the cannula was intubated to the hepatic artery by DSA. Then, 50 mg of lobaplatin plus 4 mg of raltitrexed was injected into the vascular artery. The embolic agent was selected as 38.0. % super liquefied iodine solution and / or gelatin sponge particles, the dose is maintained at 5 ~ 20ml. At the end of treatment, a DSA examination again confirmed that the tumor was completely occluded. | Drug | Postoperative TACE group |
Primary outcome
overall survival
Time frame: 5years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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 Postoperative radiotherapy and Postoperative TACE in people with HepatoCellular Carcinoma, run by Guangxi Medical 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 6 inclusion and 6 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 10 Jul 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 Tao Bai, MD (+86 13878862632, 25859373@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5years). 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 10 Jul 2018.