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

NCT04619329 | Unknown

• 1 other identifier: 20200-0-02
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Huge Hepatocellular Carcinoma (HCC) (≥10cm)

Outcome Measures

Primary Outcomes (2)

• Disease Free Survival（DFS）

  6 months

• Median Overall Survival (mOS)

  2 years

Secondary Outcomes (4)

• Incidence of Intrahepatic Metastasis

  6 months

• Incidence of Extrahepatic Metastasis

  1 and 2 years

• Overall Survival (OS)

  1 and 2 years

• Adverse Events

  6 months

Study Arms (2)

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.

Device: GSMs-TACE; Procedure: Surgical Resection

Surgical Resection Group

ACTIVE COMPARATOR

Patients will receive surgical resection, as specified per protocol.

Procedure: Surgical Resection

Interventions

GSMs-TACE DEVICE

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

Also known as: TACE

GSMs-TACE+ Surgical Resection Group

Surgical Resection PROCEDURE

Surgical Resection of HCC

Also known as: Hepatectomy

GSMs-TACE+ Surgical Resection Group; Surgical Resection Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Hepatectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Yuewei Zhang

CONTACT

00861800115669; zhangyuewei1121@sina.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 6, 2020
• Study Start: October 30, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

CN (1)