HCCESCALATORNCT03097848
Efficacy and Safety of Sorafenib as Adjuvant and Latter Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma
A study testing RFA and Sorafenib in people with HCC, run by Southwest Hospital, China at 1 site in China.
Trial summary
Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC
- What is being tested?
- RFA and Sorafenib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2017to 31 Dec 2018
- 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 from 18 to 75 years old
- Without gender restriction
- With a favorable liver function of Child-Pugh A to B
- No contraindications to RFA and anesthesia
- Diagnosed with Recurrent HCC
- Signed informed consent.
Who cannot join
- Cancer thrombosis in major vessels/ extrahepatic metastasis
- Uncontrollable ascites or variceal bleeding
- Impairment in liver function
- Severe disorders in vital organ
- Accompanied with other tumors or infectious disease except hepatitis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
kuansheng Ma, MD
About this study
Official title: Efficacy and Safety of Combination of Sorafenib as Preoperative Adjuvant and Latter Radiofrequency Ablation in the Treatment Of Recurrent Hepatocellular Carcinoma: A Prospective Multicenter Cohort Study
Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study.
Read the detailed description
Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study. Eligible cases will be assigned into the experimental group and the control group. For experiment group, sorafenib tablet will be given for two weeks, and then perform radiofrequency ablation. For the control group, RFA will be performed immediately.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFAProcedure or surgery
Also called control group
for eligible cases, radiofrequency ablation will be given only.
SorafenibDrug
Also called experimental group
for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib+RFA group | Experimental | for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation Receives: Procedure: RFA; Drug: Sorafenib |
| RFA group | Active comparator | for eligible cases, RFA will be given only. Receives: Procedure: RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
1 year Disease free survival
Measured: 1 year
Secondary outcomes (5)
Time To Recurrence
time to tumor recurrence
Measured: 3 year
Overall Survival
overall survival
Measured: 3 year
postoperative complications
postoperative complications diagnosed within 6 months
Measured: 6 months
Health economics index
Health economics index within 3 years
Measured: 3 years
mortality
mortality occured within 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start4 May 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu PLA General Hospital, Sichuan Provincial People's Hospital, Sichuan Cancer Hospital and Research Institute, Hunan Cancer Hospital, Cancer Hospital of Guangxi Medical University, The First People's Hospital of Yunnan, Yunnan Cancer Hospital, Xiangya Hospital of Central South University, Xinqiao Hospital of Chongqing, The Second Affiliated Hospital of Chongqing Medical University, Henan Cancer Hospital, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, feng xiaobin, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097848
- Sponsor's protocol ID
- SWHB 019
- Acronym
- ESCALATOR
- Status last verified
- Mar 2017
- First submitted
- 21 Mar 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combination of Sorafenib as Preoperative Adjuvant and Latter Radiofrequency Ablation in the Treatment Of Recurrent Hepatocellular Carcinoma: A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT03097848
- Acronym / sponsor ID
- ESCALATOR / SWHB 019
- Conditions
- HCC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Collaborators
- Chengdu PLA General Hospital, Sichuan Provincial People's Hospital, Sichuan Cancer Hospital and Research Institute, Hunan Cancer Hospital, Cancer Hospital of Guangxi Medical University, The First People's Hospital of Yunnan, Yunnan Cancer Hospital, Xiangya Hospital of Central South University, Xinqiao Hospital of Chongqing, The Second Affiliated Hospital of Chongqing Medical University, Henan Cancer Hospital, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Guangxi Medical University
- Study start
- 4 May 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 31 Mar 2017 (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.
Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study.
Detailed description
Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study. Eligible cases will be assigned into the experimental group and the control group. For experiment group, sorafenib tablet will be given for two weeks, and then perform radiofrequency ablation. For the control group, RFA will be performed immediately.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sorafenib+RFA group | Experimental | Procedure: RFA, Drug: Sorafenibfor eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation |
| RFA group | Active comparator | Procedure: RFAfor eligible cases, RFA will be given only. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged from 18 to 75 years old
- Without gender restriction
- With a favorable liver function of Child-Pugh A to B
- No contraindications to RFA and anesthesia
- Diagnosed with Recurrent HCC
Key exclusion criteria (5 listed)
- Cancer thrombosis in major vessels/ extrahepatic metastasis
- Uncontrollable ascites or variceal bleeding
- Impairment in liver function
- Severe disorders in vital organ
- Accompanied with other tumors or infectious disease except 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 |
|---|---|---|
| RFAAlso: control groupfor eligible cases, radiofrequency ablation will be given only. | Procedure or surgery | RFA group, Sorafenib+RFA group |
| SorafenibAlso: experimental groupfor eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation | Drug | Sorafenib+RFA group |
Primary outcome
Disease free survival
Time frame: 1 year
1 year Disease free survival
5 secondary outcomes
Time To Recurrence
Time frame: 3 year
Overall Survival
Time frame: 3 year
postoperative complications
Time frame: 6 months
Health economics index
Time frame: 3 years
mortality
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Individual participant dataSharing planned: Undecided
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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 RFA and Sorafenib in people with HCC, run by Southwest Hospital, China 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 5 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 8 May 2017. 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 Xiaobin Feng (+86-2368765297, fengxiaobin200708@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 1 year). 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 8 May 2017.