MedDataX Logo

Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm)

NCT ID: NCT04619329

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-30

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Huge Hepatocellular Carcinoma (HCC) (≥10cm)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

GSMs-TACE

Intervention Type DEVICE

TACE using Lobaplatin (30-40mg/m2) and gelatin sponge microspheres (150-350μm, 350-560μm, 560-710μm or 710-1000μm)

Surgical Resection

Intervention Type PROCEDURE

Surgical Resection of HCC

Surgical Resection Group

Patients will receive surgical resection, as specified per protocol.

Group Type ACTIVE_COMPARATOR

Surgical Resection

Intervention Type PROCEDURE

Surgical Resection of HCC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GSMs-TACE

TACE using Lobaplatin (30-40mg/m2) and gelatin sponge microspheres (150-350μm, 350-560μm, 560-710μm or 710-1000μm)

Intervention Type DEVICE

Surgical Resection

Surgical Resection of HCC

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TACE Hepatectomy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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).
2. Barcelona Clinic Liver Cancer (BCLC) stage A or B.
3. Remnant liver volume and liver function reserve are suitable for surgical resection.
4. Main lesion diameter ≥10cm.
5. Number of HCC lesions ≤5 and all located on one liver lobe.
6. Liver function Child-Pugh class A
7. ECOG Performance Status 0-1
8. Life expectancy ≥ 6 months
9. HCC is diagnosed for the first time.
10. Age 18 to 75 years
11. Able to sign and provide written informed consent.

Exclusion Criteria

1. Severe active infection \>grade 2 (except for Hepatitis B and C infection).
2. Liver function Child-Pugh class C.
3. BCLC stage C.
4. Patients with unresectable HCC.
5. Platelet \<60×109/L.
6. Concomitant malignant tumors in other organs.
7. Patient with severe cardiac, lung or kidney disease, or severe diabetes.
8. Pregnant or breast-feeding woman.
9. Patients with severe neuropathy and unable to report therapeutic effects.
10. Patients with severe atherosclerosis.
11. Patients with AIDS.
12. Severe hemorrhage of digestive tract within the 4 weeks prior to enrolment.
13. Severe thrombogenesis or embolic event within the 6 months prior to enrolment.
14. Currently enrolled or going to enroll in any other clinical trials.
15. Subject is not suitable to participate in the study as judged by investigator (poor patient compliance，inability to follow up).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Tsinghua Changgung Hospital

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yuewei Zhang

Role: CONTACT

Phone: 00861800115669

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yuewei Zhang

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20200-0-02

Identifier Type: -

Identifier Source: org_study_id