NCT04417764

Brief Summary

This study will evaluate the safety and effect of transcatheter arterial chemoembolization (TACE)combined with percutaneous transhepatic PD-1 knockout engineered T cell infusion in the Paitents with advanced hepatocellular carcinoma(HCC). Blood and tissue samples will also be collected for research purposes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

5.5 years

First QC Date

May 29, 2020

Last Update Submit

February 7, 2023

Conditions

Advanced Hepatocellular Carcinoma

Keywords

CRISPR Cas 9TACEPD-1 knockout engineered T cellsAdvanced hepatocellular carcinomaLocally administered treatment

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events

    Number of participants with Adverse Events using Common Terminology Criteria for Adverse Events (CTCAE v4.03) in patients.

    up to 2 years

Secondary Outcomes (5)

  • Response Rate

    up to 12 months

  • Time to First Response

    up to 2 years

  • Duration of Response

    up to 2 years

  • Progression Free Survival

    up to 2 years

  • Overall Survival

    up to 2 years

Study Arms (1)

TACE combined PD-1 knockout T cell treatment

EXPERIMENTAL
Procedure: Transcatheter arterial chemoembolizationBiological: PD-1 knockout engineered T cells

Interventions

Transcatheter arterial chemoembolizationPROCEDURE

The patients are plan to operated by Transcatheter arterial chemoembolization(TACE).

TACE combined PD-1 knockout T cell treatment
PD-1 knockout engineered T cellsBIOLOGICAL

The PD-1 knockout engineered T cells are prepared from autologous origin using CRISPR Cas9 technology. The patients are plan to receive 3 or more cycles of PD-1 knockout engineered T cells infusion by percutaneous fine needle liver puncture with a 4-weeks interval. A total of 1 to 3× 10\^9 PD-1 edited T cells will be infused each cycle. Patients continued receiving treatment unless they had unacceptable adverse effects, or progressive disease confirmed by CT or they withdrew consent.

TACE combined PD-1 knockout T cell treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with unresectable hepatocellular carcinoma;
  • More than 18 years old;
  • Patients diagnosed with hepatocellular carcinoma by histopathology or imagings;
  • Liver function ChildPugh ≤7 points, Physical strength score ECOG-pts 0-1 points;
  • Maximum tumor diameter ≤10cm, tumor number ≤10, no vascular invasion or extrahepatic metastasis;
  • Other organs of the whole body function well;
  • Sign the informed consent;
  • Passed the review by the ethics committee.

You may not qualify if:

  • Less than 18 or more than 70 years old;
  • Lack of autonomous decision-making ability;
  • ECOG score \>2, cachexia or multiple organ failure;
  • Metastases; The tumor was diffuse or metastasized widely and the expected survival time was less than 3 months.
  • Uncorrectable coagulation dysfunction with a history of bleeding; Organ transplant;
  • Patients with severe autoimmune diseases; Iodine contrast agent allergy; High allergic constitution;
  • The main portal vein was completely blocked by cancer embolism, with little collateral vascular formation;
  • Severe infection; AIDS, syphilis infection;
  • T cell lymphoma;
  • Patients with mental illness, severe trauma or other stress conditions;
  • Pregnant or nursing women;
  • Abnormal peripheral blood routine detection;
  • Failing to comply with the study protocol to complete the diagnosis and treatment project; Failed ethics committee review.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 3rd Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

Central Study Contacts

Wei Wang, MD

CONTACT

86-0731-88618411cjr.wangwei@vip.163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal for The Institute for Cell Transplantation and Gene Therapy

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 5, 2020

Study Start

June 20, 2019

Primary Completion

December 30, 2024

Study Completion

December 31, 2024

Last Updated

February 9, 2023

Record last verified: 2023-02

Locations

CN(1)