Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in the Treatment of Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)

NCT04619342 | Unknown

• 1 other identifier: 20304-0-01
• Study Type: interventional
• Target: 98
• 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 the Treatment of Hepatocellular Carcinoma (HCC) with Type III Portal Vein Tumor Thrombus (PVTT).

Conditions

Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival（PFS）

  PFS is defined as the time from Day 1 of treatment until the progression of a target lesion or the appearance of new lesions.

  6 months

Secondary Outcomes (3)

• Median Overall Survival (mOS)

  2 years

• Overall Survival

  3, 6, 12 and 18 months

• Adverse Events

  6 months

Study Arms (2)

GSMs-TACE+ Surgical Resection Group

EXPERIMENTAL

After TACE using epirubicin and GSMs (150-350μm or 350-560μm), patients that meet certain criteria will receive surgical resection of PVTT, as specified per protocol.

Device: GSMs-TACE; Procedure: Surgical Resection

GSMs-TACE Group

ACTIVE COMPARATOR

Patients will receive TACE using epirubicin and GSMs (150-350μm or 350-560μm), as specified per protocol.

Device: GSMs-TACE

Interventions

GSMs-TACE DEVICE

TACE using epirubicin (30-40mg/m2) and gelatin sponge microspheres (150-350μm or 350-560μm)

Also known as: TACE

GSMs-TACE Group; GSMs-TACE+ Surgical Resection Group

Surgical Resection PROCEDURE

Surgical Resection of PVTT

GSMs-TACE+ 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 diagnosis of HCC with PVTT involving the main portal vein, i.e. Type III PVTT according to Cheng's classification.
• Confirmed abundant blood supply of tumor thrombus using Computed Tomography (CT) and Magnetic Resonance Imaging (MRI).
• The tumor must be surgically resectable.
• ECOG Performance Status 0-2.
• Adequate liver function (Child-Pugh class A)
• Life expectancy ≥ 3 months
• Previous physical ablation is allowed.
• Age 18 to 75 years
• Able to sign and provide written informed consent.

You may not qualify if:

• Patients previously took oral molecular targeted drug or received immunotherapy.
• Patients with arteriovenous fistula.
• Severe active infection \>grade 2 (except for Hepatitis B and C infection).
• Concomitant malignant tumors in other organs.
• Presence of severe cardiac, lung or kidney disease.
• 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 Changgung Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yuewei Zhang

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

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: June 30, 2021
• Study Completion: December 31, 2022
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

CN (1)