Postoperative TACE(Transhepatic Arterial Chemotherapy And Embolization) for Patients With Hepatocellular Carcinoma

NCT02109146 | Completed Phase 3

• 1 other identifier: 2014-103
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Hepatocellular carcinoma (HCC) is the most common primary malignancy of liver, representing the third leading cause of cancer-related death worldwide.
2. 2.Its overall dismal prognosis is a result of high incidence rates of metastasis and postoperative recurrence, in particular the intrahepatic recurrence.
3. 3.TACE is the most widely used primary treatment for unresectable HCC. It was also used as the optional treatment for relapsed disease. However, the efficacy of TACE used as adjuvant therapy following hepatectomy remains controversial.

Conditions

Hepatocellular Carcinoma; Transcatheter Arterial Chemoembolization

Keywords

TACE; Postoperation

Outcome Measures

Primary Outcomes (1)

• RFS(Recurrence free survival)

  defined as the time from randomization to the first documented HCC recurrence by independent radiological assessment or death due to any cause, whichever occurred first.

  the time from randomization to the first documented HCC recurrence by independent radiological assessment or death due to any cause, whichever occurred first，assessed up to 120 months

Secondary Outcomes (3)

• OS (overall survival)

  defined as the time from randomization to death due to any cause, assessed up to 120 months

• RFS rate

  the time from randomization to the first documented HCC recurrence by independent radiological assessment or death due to any cause, whichever occurred first，assessed up to 120 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  up to 24 weeks

Study Arms (2)

Adjuvant TACE

EXPERIMENTAL

Patients receive adjuvant Transcatheter Arterial Chemoembolization (TACE) following curative resection of HCC.

Drug: Prophylactic Transcatheter Arterial Chemoembolization

Observation

ACTIVE COMPARATOR

Patients do not receive TACE or any other adjuvant therapy following curative resection of HCC.

Other: Observation

Interventions

Prophylactic Transcatheter Arterial Chemoembolization DRUG

Participants enrolled in the adjuvant TACE group received one to two cycles of TACE with an interval of 4\~6 weeks, and the first TACE was given within 1 week after randomization.

Adjuvant TACE

Observation OTHER

Participants enrolled in the observation group were subjected to active surveillance without any adjuvant treatment.

Observation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological diagnosis of HCC (AJCC stage I or II)
• Without recurrence in 1 month postoperation
• Must be tolerant to TACE

You may not qualify if:

• With intrahepatic recurrence postoperation
• Insufficient liver function
• Stage III or IV

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Observation

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Tingbo Liang, M.D Ph.D

  Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: After confirming eligibility by the investigators, patients without residual tumors on the CT/MRI were consented and randomly assigned in a 1:1 ratio into the adjuvant TACE group or the observation group. Allocation of treatment group was done with a computer-generated random number list.

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 9, 2014
• Study Start: March 26, 2014
• Primary Completion: May 13, 2023
• Study Completion: May 13, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

CN (1)