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Phase 2 Completed N=52 Treatment

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

Hepatocellular Carcinoma · Malignant Neoplasm
Source: ClinicalTrials.gov NCT03575806 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Recurrence-free Survival (RFS) Time — 9.5; 12 months

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).

Outcome Measures

OutcomeResultp-value
PRIMARY
Recurrence-free Survival (RFS) Time
9.5; 12
SECONDARY
Overall Survival (OS) Rate at 24 Months
25; 23; 0; 0

Eligibility Criteria

Inclusion Criteria

  • 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.

  • 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

  • Uncontrolled Ascites by diuretic treatment.
  • History of encephalopathy.
  • Gastrointestinal hemorrhage in 30 days before the study.
  • History of esophageal variceal hemorrhage and it is no effective treatment to prevent the recurrence of hemorrhage.
  • Major surgery except radical hepatic resection was performed in 4 weeks before the study.
  • Autologous bone marrow transplantation (ABMT) in 4 weeks before the study.
  • Concurrent treatment on another clinical trial or treatment on another clinical trial in 4 weeks before the study.
  • Drug abuse, medical treatment, mental illness or social disorders that would interfere with subjects' participation, or confound the results of the trial.
  • Any condition that would interfere with or endanger the safety and compliance of subjects.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03575806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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