NCT01906632

Brief Summary

To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor after DC-CIK immunotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

9.7 years

First QC Date

July 21, 2013

Last Update Submit

February 5, 2024

Conditions

Malignant Tumor

Outcome Measures

Primary Outcomes (1)

  • T-Cell Receptor/B-Cell Receptor gene expression

    3 month

Study Arms (1)

gene expression profile

OTHER
Biological: DC-CIK Immunotherapy

Interventions

DC-CIK ImmunotherapyBIOLOGICAL
gene expression profile

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed with malignant tumor;
  • Age: 18-80 years;
  • an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • At least one measurable lesion according to the RECIST criteria;
  • Adequate bone marrow, cardiac, liver, and renal function;
  • Life expectancy ≥2 months;
  • Not received other anti-tumor treatment
  • Informed consent signed

You may not qualify if:

  • previous history of other malignancies;
  • Uncontrolled central nervous system metastases;
  • Serious or uncontrolled concurrent medical illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Beijing, 100038, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Capita Medical University Cancer Center

Study Record Dates

First Submitted

July 21, 2013

First Posted

July 24, 2013

Study Start

May 1, 2013

Primary Completion

December 30, 2022

Study Completion

June 30, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

CN(1)