- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04619329
Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm)
November 26, 2020 updated by: Beijing Tsinghua Chang Gung Hospital
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Recruiting
- Beijing Tsinghua Changgung Hospital
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Contact:
- Yuewei Zhang
- Phone Number: +8618001156699 00861800115669
- Email: zhangyuewei1121@sina.com.cn
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: GSMs-TACE+ Surgical Resection Group
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.
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TACE using Lobaplatin (30-40mg/m2) and gelatin sponge microspheres (150-350μm, 350-560μm, 560-710μm or 710-1000μm)
Other Names:
Surgical Resection of HCC
Other Names:
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ACTIVE_COMPARATOR: Surgical Resection Group
Patients will receive surgical resection, as specified per protocol.
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Surgical Resection of HCC
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Median Overall Survival (mOS)
Time Frame: 2 years
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2 years
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Disease Free Survival(DFS)
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events
Time Frame: 6 months
|
6 months
|
Incidence of Intrahepatic Metastasis
Time Frame: 6 months
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6 months
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Incidence of Extrahepatic Metastasis
Time Frame: 1 and 2 years
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1 and 2 years
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Overall Survival (OS)
Time Frame: 1 and 2 years
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1 and 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 30, 2020
Primary Completion (ANTICIPATED)
December 31, 2022
Study Completion (ANTICIPATED)
December 31, 2022
Study Registration Dates
First Submitted
November 3, 2020
First Submitted That Met QC Criteria
November 3, 2020
First Posted (ACTUAL)
November 6, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 30, 2020
Last Update Submitted That Met QC Criteria
November 26, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200-0-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Huge Hepatocellular Carcinoma (HCC) (≥10cm)
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BayerNot yet recruitingHepatocellular Carcinoma (HCC)United States
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Chugai PharmaceuticalRecruitingHepatocellular Carcinoma (HCC)Taiwan, Japan
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Bristol-Myers SquibbCompletedHepatocellular Carcinoma (HCC)France, Korea, Republic of, Taiwan, United States, Singapore, Philippines, Malaysia, Hong Kong
-
Institut für Klinische Krebsforschung IKF GmbH...Active, not recruitingHepatocellular Carcinoma (HCC)Germany
-
Boston Scientific CorporationBiocompatabilities UK LtdWithdrawnHepatocellular Carcinoma (HCC)
-
University Hospital, BordeauxCompleted
-
Shanghai Zhongshan HospitalWest China Hospital; Tongji Hospital; Anhui Provincial HospitalUnknownHepatocellular Carcinoma (HCC)China
-
Medical College of WisconsinNorthwestern University; GuerbetCompletedHepatocellular Carcinoma (HCC)United States
-
University Hospital, MontpellierCompleted
-
Shanghai Junshi Bioscience Co., Ltd.Active, not recruitingAdvanced Hepatocellular Carcinoma (HCC)China, Singapore
Clinical Trials on GSMs-TACE
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Beijing Tsinghua Chang Gung HospitalUnknownHepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)China
-
Sun Yat-sen UniversityUnknownHepatocellular Carcinoma | Liver CancerChina
-
Shanghai Zhongshan HospitalRecruitingA Real-world Study of Donafenib Combined With TACE-based Treatment in Patients With Unresectable HCCHepatocellular Carcinoma | DonafenibChina
-
Eastern Hepatobiliary Surgery HospitalCompletedHepatocellular CarcinomaChina
-
Sun Yat-sen UniversityUnknownHepatocellular Carcinoma | Liver CancerChina
-
Fudan UniversityUnknownHepatocellular CarcinomaChina
-
Kindai UniversityUnknownCarcinoma, Hepatocellular | Hepatocellular Carcinoma | Liver Neoplasm | Unresectable Hepatocellular CarcinomaJapan
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Ivy Life Sciences, Co., LtdTri-Service General HospitalUnknownLiver Cancer | HepatoCellular CarcinomaTaiwan
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Assiut UniversityUnknown
-
Zhongda HospitalRecruiting