Combine TACE and Autologous Tcm Immunotherapy Versus TACE Alone for HCC With MVI After Radical Resection

NCT03575806 | Completed Phase 2 Results DMC

• 1 other identifier: CancerIHCAMS-HCC-Tcm
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of combining autologous Tcm immunotherapy and TACE in HCC patients with MVI after radical resection. Patients will be assigned either to the experimental arm to receive autologous Tcm immunotherapy and TACE or to the active comparator (TACE alone).

Conditions

Hepatocellular Carcinoma; Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Recurrence-free Survival (RFS) Time

  Recurrence-free survival was defined as the interval (in months) between hepatectomy and diagnosis of recurrence using either intrahepatic recurrence or extrahepatic metastasis.

  12 months

Secondary Outcomes (1)

• Overall Survival (OS) Rate at 24 Months

  24 months

Study Arms (2)

TACE+Tcm group

EXPERIMENTAL

Experimental arm: TACE plus autologous Tcm immunotherapy to treat HCC.

Combination Product: TACE plus autologous Tcm immunotherapy

TACE group

ACTIVE COMPARATOR

Active comparator: TACE to treat HCC.

Procedure: TACE

Interventions

TACE plus autologous Tcm immunotherapy COMBINATION_PRODUCT

TACE:transcatheter arterial chemoembolization. Autologous Tcm immunotherapy: to collect patient's own immune cells and then given back to the patient after amplified in vitro.

TACE+Tcm group

TACE PROCEDURE

TACE:transcatheter arterial chemoembolization.

TACE 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:

• Be willing and able to provide written informed consent for the study.
• Subject has accepted radical hepatic resection, and preoperative imaging is no vascular invasion.
• Postoperative pathology confirmed Hepatocellular carcinoma with negative margin and microvascular invasion (MVI).
• Age between 18-75 years old.
• Radiology confirmed complete response (CR) after radical surgery.
• Child-Pugh A.
• Eastern Cooperative Oncology Group(ECOG) body condition score 0.
• Adequate hepatic and renal function:
• Hemoglobin ≥ 9.0g/dl. Absolute neutrophil count (ANC) \> 1,500/mm3. Platelets ≥ 50,000/ul. Total bilirubin (TBIL) ≤ 2mg/dl. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 the upper limit of normal (ULN) for the institution.
• Alkaline phosphatase (ALP) ≤ 4 the upper limit of ULN. Prothrombin time (PT) \> 50% or prothrombin time-international normalized ratio (PT-INR) \< 2.3.
• Serum creatinine (CREA) ≤ 1.5 the upper limit of ULN.
• Female subjects have had a negative blood pregnancy test within 2 week,
• Subjects be willing to use appropriate contraception during the trial and 2 weeks after the last administration of immunotherapy.
• Radiology such as CT and MRI were performed in 4 weeks before the study.

You may not qualify if:

• Recurrent HCC.
• Portal vein embolus.
• Cardiovascular disease:
• Evidence of NYHA functional class III or IV heart disease. Unstable coronary artery disease (CAD) is not allowed, while Myocardial Infarction (MI) 6 months of starting study is allowed.
• Cardiac arrhythmias requiring antiarrhythmic drugs except β-blockers or digoxin are not allowed.
• Uncontrolled hypertension.
• History of Human Immunodeficiency Virus (HIV) or syphilis infection.
• Severe inflammation, NCI CTCAE Version 3.0 grade \> 2.
• Epilepsy requiring steroid or antiepileptic drugs.
• History of allotransplantation.
• History or any evidence of hemorrhage.
• Subjects undergoing renal dialysis.
• Pregnancy or breast-feeding.
• Prior or undergoing cancers that primary sites are different from the carcinoma of this study. Exceptions to this are:
• Cervical carcinoma in situ (CIS) Cured basal cell carcinoma Superficial bladder tumor Cured cancers over 3 years before the study

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Newish Technology (Beijing) Co., Ltd.: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (1)

• Cai J, Zhao J, Liu D, Xie H, Qi H, Ma J, Sun Z, Zhao H. Efficacy and Safety of Central Memory T Cells Combined With Adjuvant Therapy to Prevent Recurrence of Hepatocellular Carcinoma With Microvascular Invasion: A Pilot Study. Front Oncol. 2021 Dec 3;11:781029. doi: 10.3389/fonc.2021.781029. eCollection 2021.

  PMID: 34926296 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasms

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This study was a pilot study with small sample size, which would influence the statistical results.

Results Point of Contact

• Title: Statistician of Clinical Trials
• Organization: Tsinghua University

majunfan2@sina.com

Study Officials

• Hong Zhao

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant director physician

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: July 3, 2018
• Study Start: January 9, 2017
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: June 11, 2020
• Results First Posted: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)