Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03575806
Other study ID # CancerIHCAMS-HCC-Tcm
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 9, 2017
Est. completion date October 31, 2019

Study information

Verified date May 2020
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

Hepatocellular carcinoma (HCC) is one of the common cancer worldwide, which is the third cause of cancer related deaths. Radical hepatic resection remains the main treatment for hepatocellular carcinoma, the 5-year survival rate of HCC after surgery was 60-70%. Unfortunately, HCC is prone to postoperative recurrence that more than 50% of patients relapse within 2 years, which has become the key to restrict the therapeutic effect of hepatocellular carcinoma. Microvascular invasion (MVI) is one of the main risk factors for poor prognosis in HCC.

Autologous cell immunotherapy is to collect patient's own immune cells and then given back to the patient after amplified in vitro that can improve the anti-tumor immune response. Tcm (central memory T cells) are effective anti-tumor immune cells that exhibit the long-term survival and self-renewal capacity in vivo. Autologous Tcm immunotherapy combining chemotherapy, surgery or radiotherapy would effectively prolong survival period, prevent tumor recurrence and metastasis, then improve quality of life in patients.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Be willing and able to provide written informed consent for the study.

2. Subject has accepted radical hepatic resection, and preoperative imaging is no vascular invasion.

3. Postoperative pathology confirmed Hepatocellular carcinoma with negative margin and microvascular invasion (MVI).

4. Age between 18-75 years old.

5. Radiology confirmed complete response (CR) after radical surgery.

6. Child-Pugh A.

7. Eastern Cooperative Oncology Group(ECOG) body condition score 0.

8. 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.

9. Female subjects have had a negative blood pregnancy test within 2 week,

10. Subjects be willing to use appropriate contraception during the trial and 2 weeks after the last administration of immunotherapy.

11. Radiology such as CT and MRI were performed in 4 weeks before the study.

Exclusion Criteria:

1. Recurrent HCC.

2. Portal vein embolus.

3. 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 ß-blockers or digoxin are not allowed.

Uncontrolled hypertension.

4. History of Human Immunodeficiency Virus (HIV) or syphilis infection.

5. Severe inflammation, NCI CTCAE Version 3.0 grade > 2.

6. Epilepsy requiring steroid or antiepileptic drugs.

7. History of allotransplantation.

8. History or any evidence of hemorrhage.

9. Subjects undergoing renal dialysis.

10. Pregnancy or breast-feeding.

11. 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

12. Uncontrolled Ascites by diuretic treatment.

13. History of encephalopathy.

14. Gastrointestinal hemorrhage in 30 days before the study.

15. History of esophageal variceal hemorrhage and it is no effective treatment to prevent the recurrence of hemorrhage.

16. Major surgery except radical hepatic resection was performed in 4 weeks before the study.

17. Autologous bone marrow transplantation (ABMT) in 4 weeks before the study.

18. Concurrent treatment on another clinical trial or treatment on another clinical trial in 4 weeks before the study.

19. Drug abuse, medical treatment, mental illness or social disorders that would interfere with subjects' participation, or confound the results of the trial.

20. Any condition that would interfere with or endanger the safety and compliance of subjects.

Study Design


Intervention

Combination Product:
TACE plus autologous Tcm immunotherapy
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.
Procedure:
TACE
TACE:transcatheter arterial chemoembolization.

Locations

Country Name City State
China Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Newish Technology (Beijing) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall Survival (OS) Rate at 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. 24 months
See also
  Status Clinical Trial Phase
Recruiting NCT04209491 - Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
Completed NCT03963206 - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE) Phase 4
Completed NCT03268499 - TACE Emulsion Versus Suspension Phase 2
Recruiting NCT05044676 - Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
Recruiting NCT05263830 - Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
Recruiting NCT05095519 - Hepatocellular Carcinoma Imaging Using PSMA PET/CT Phase 2
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Completed NCT05068193 - A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers Phase 1
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Terminated NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Completed NCT04401800 - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma Phase 2
Withdrawn NCT05418387 - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona N/A
Active, not recruiting NCT04039607 - A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma Phase 3
Terminated NCT03970616 - A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT06239155 - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03642561 - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE Phase 2/Phase 3
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Completed NCT03222076 - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer Phase 2