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NCT03575806

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

Completed Phase 2 Results posted Last updated 11 June 2020
What this trial tests

Phase 2 trial testing TACE plus autologous Tcm immunotherapy in Hepatocellular Carcinoma in 52 participants. Completed in 31 October 2019.

Timeline
9 January 2017
Primary endpoint
31 October 2019
31 October 2019

Quick facts

Lead sponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment52
Start date9 January 2017
Primary completion31 October 2019
Estimated completion31 October 2019
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Who can join

Adults 18 to 75, any sex, with Hepatocellular Carcinoma or Malignant Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recurrence-free Survival (RFS) Time Primary · 12 months

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

GroupValue95% CI
TACE Group9.5± 3.99
TACE+Tcm Group12± 3.24
Overall Survival (OS) Rate at 24 Months Secondary · 24 months

Overall survival rate = the number of patients in TACE/TACE+Tcm group survived at 24 months/the number of total patients assigned into TACE/TACE+Tcm group.

GroupValue95% CI
TACE Group25
TACE+Tcm Group23
TACE Group0
TACE+Tcm Group0

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TACE Group
Serious: 0/25 (0%)
Deaths: 0/25
TACE+Tcm Group
Serious: 0/26 (0%)
Deaths: 0/26
Other adverse events (2 terms — click to expand)

ReactionSystemTACE GroupTACE+Tcm Group
Hepatic painHepatobiliary disorders
Bone marrow hypocellularBlood and lymphatic system disorders

Data from ClinicalTrials.gov NCT03575806 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Memory T cells: strategies for optimizing tumor immunotherapy.
    Liu Q, Sun Z, Chen L. · · 2020 · cited 251× · PMID 32221812 · DOI 10.1007/s13238-020-00707-9
  2. Combined locoregional-immunotherapy for liver cancer.
    Greten TF, Mauda-Havakuk M, Heinrich B, Korangy F, et al · · 2019 · cited 169× · PMID 30738077 · DOI 10.1016/j.jhep.2019.01.027
  3. Inflammatory Mechanisms of HCC Development.
    Refolo MG, Messa C, Guerra V, Carr BI, et al · · 2020 · cited 149× · PMID 32164265 · DOI 10.3390/cancers12030641
  4. The Immune Modulation Effect of Locoregional Therapies and Its Potential Synergy with Immunotherapy in Hepatocellular Carcinoma.
    Singh P, Toom S, Avula A, Kumar V, et al · · 2020 · cited 76× · PMID 32104669 · DOI 10.2147/jhc.s187121
  5. Cell death pathologies: targeting death pathways and the immune system for cancer therapy.
    Pentimalli F, Grelli S, Di Daniele N, Melino G, et al · · 2019 · cited 48× · PMID 30563970 · DOI 10.1038/s41435-018-0052-x
  6. Cellular based immunotherapy for primary liver cancer.
    Zheng Y, Li Y, Feng J, Li J, et al · · 2021 · cited 24× · PMID 34372912 · DOI 10.1186/s13046-021-02030-5
  7. A Correlation Between Differentiation Phenotypes of Infused T Cells and Anti-Cancer Immunotherapy.
    Ren H, Cao K, Wang M. · · 2021 · cited 21× · PMID 34603332 · DOI 10.3389/fimmu.2021.745109
  8. Molecular Imaging of Tumor Microenvironment to Assess the Effects of Locoregional Treatment for Hepatocellular Carcinoma.
    Chen Q, Chen AZ, Jia G, Li J, et al · · 2022 · cited 12× · PMID 34738743 · DOI 10.1002/hep4.1850

Verify or expand the search:

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

Other Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials

Trials by the same sponsor.

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