Huge Hepatocellular Carcinoma (HCC) (≥10cm)NCT04619329
Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm)
A study testing GSMs-TACE and Surgical Resection in people with Huge Hepatocellular Carcinoma (HCC) (≥10cm), run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
A Single center, Open, Randomized Controlled Trial Evaluating the Safety and Efficacy of GSMs-TACE combined with Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Huge Hepatocellular Carcinoma (HCC) (≥10cm)
- What is being tested?
- GSMs-TACE and Surgical Resection
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2020to 31 Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed imaging and pathological diagnosis of HCC, or diagnosed for the first time according to the guidelines for diagnosis and treatment of primary liver cancer in China (2019 edition).
- Barcelona Clinic Liver Cancer (BCLC) stage A or B.
- Remnant liver volume and liver function reserve are suitable for surgical resection.
- Main lesion diameter ≥10cm.
- Number of HCC lesions ≤5 and all located on one liver lobe.
- Liver function Child-Pugh class A
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- ECOG Performance Status 0-1
- Life expectancy ≥ 6 months
- HCC is diagnosed for the first time.
- Age 18 to 75 years
- Able to sign and provide written informed consent.
Who cannot join
- Severe active infection >grade 2 (except for Hepatitis B and C infection).
- Liver function Child-Pugh class C.
- BCLC stage C.
- Patients with unresectable HCC.
- Platelet <60×109/L.
- Concomitant malignant tumors in other organs.
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- Patient with severe cardiac, lung or kidney disease, or severe diabetes.
- Pregnant or breast-feeding woman.
- Patients with severe neuropathy and unable to report therapeutic effects.
- Patients with severe atherosclerosis.
- Patients with AIDS.
- Severe hemorrhage of digestive tract within the 4 weeks prior to enrolment.
- Severe thrombogenesis or embolic event within the 6 months prior to enrolment.
- Currently enrolled or going to enroll in any other clinical trials.
- Subject is not suitable to participate in the study as judged by investigator (poor patient compliance，inability to follow up).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing
Yuewei Zhang, 00861800115669 ext. +8618001156699, zhangyuewei1121@sina.com.cn
About this study
Official title: Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm): A Single Center, Open, Randomized Controlled Trial.
A Single center, Open, Randomized Controlled Trial Evaluating the Safety and Efficacy of GSMs-TACE combined with Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm).
- Being tested
- GSMs-TACE, Surgical Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSMs-TACEDevice
Also called TACE
TACE using Lobaplatin (30-40mg/m2) and gelatin sponge microspheres (150-350μm, 350-560μm, 560-710μm or 710-1000μm)
Surgical ResectionProcedure or surgery
Also called Hepatectomy
Surgical Resection of HCC
| Study group | Role | What they receive |
|---|---|---|
| GSMs-TACE+ Surgical Resection Group | Experimental | After TACE using Lobaplatin and GSMs (150-350μm, 350-560μm, 560-710μm or 710-1000μm), patients will receive surgical resection 15-30 days later, as specified per protocol. Receives: Device: GSMs-TACE; Procedure: Surgical Resection |
| Surgical Resection Group | Active comparator | Patients will receive surgical resection, as specified per protocol. Receives: Procedure: Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival（DFS）
Measured: 6 months
Median Overall Survival (mOS)
Measured: 2 years
Secondary outcomes (4)
Incidence of Intrahepatic Metastasis
Measured: 6 months
Incidence of Extrahepatic Metastasis
Measured: 1 and 2 years
Overall Survival (OS)
Measured: 1 and 2 years
Adverse Events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start30 Oct 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huge Hepatocellular Carcinoma (HCC) (≥10cm)Studies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619329
- Sponsor's protocol ID
- 20200-0-02
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 30 Nov 2020
- 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 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm): A Single Center, Open, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04619329
- Acronym / sponsor ID
- 20200-0-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Nov 2020 (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.
A Single center, Open, Randomized Controlled Trial Evaluating the Safety and Efficacy of GSMs-TACE combined with Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSMs-TACE+ Surgical Resection Group | Experimental | Device: GSMs-TACE, Procedure: Surgical ResectionAfter TACE using Lobaplatin and GSMs (150-350μm, 350-560μm, 560-710μm or 710-1000μm), patients will receive surgical resection 15-30 days later, as specified per protocol. |
| Surgical Resection Group | Active comparator | Procedure: Surgical ResectionPatients will receive surgical resection, as specified per protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Confirmed imaging and pathological diagnosis of HCC, or diagnosed for the first time according to the guidelines for diagnosis and treatment of primary liver cancer in China (2019 edition).
- Barcelona Clinic Liver Cancer (BCLC) stage A or B.
- Remnant liver volume and liver function reserve are suitable for surgical resection.
- Main lesion diameter ≥10cm.
- Number of HCC lesions ≤5 and all located on one liver lobe.
Key exclusion criteria (15 listed)
- Severe active infection >grade 2 (except for Hepatitis B and C infection).
- Liver function Child-Pugh class C.
- BCLC stage C.
- Patients with unresectable HCC.
- Platelet <60×109/L.
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 |
|---|---|---|
| GSMs-TACEAlso: TACETACE using Lobaplatin (30-40mg/m2) and gelatin sponge microspheres (150-350μm, 350-560μm, 560-710μm or 710-1000μm) | Device | GSMs-TACE+ Surgical Resection Group |
| Surgical ResectionAlso: HepatectomySurgical Resection of HCC | Procedure or surgery | GSMs-TACE+ Surgical Resection Group, Surgical Resection Group |
Primary outcome
Disease Free Survival（DFS）
Time frame: 6 months
Median Overall Survival (mOS)
Time frame: 2 years
4 secondary outcomes
Incidence of Intrahepatic Metastasis
Time frame: 6 months
Incidence of Extrahepatic Metastasis
Time frame: 1 and 2 years
Overall Survival (OS)
Time frame: 1 and 2 years
Adverse Events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
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 GSMs-TACE and Surgical Resection in people with Huge Hepatocellular Carcinoma (HCC) (≥10cm), run by Beijing Tsinghua Chang Gung Hospital 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 11 inclusion and 15 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 30 Nov 2020. 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 Yuewei Zhang (00861800115669, zhangyuewei1121@sina.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival（DFS） (time frame: 6 months). The study lists 2 primary outcomes in all. 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 30 Nov 2020.