Autologous Tcm Cells Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC)

NCT03432156 | Unknown Phase 2 DMC

• 1 other identifier: BeijingFH-JW-180202-1
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively prolong survival period and improve quality of life in patients.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

immunotherapy; NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  This study will evaluate the clinical efficacy and safety of autologous Tcm cells immunotherapy in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy according to progression-free survival (PFS) .

  12 weeks

Secondary Outcomes (1)

• Overall Survival (OS)

  12 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

subjects who are treated with autologous Tcm cells immunotherapy

Biological: Autologous Tcm cells immunotherapy

No intervention group

NO INTERVENTION

subjects who are treated without autologous Tcm cells immunotherapy

Interventions

Autologous Tcm cells immunotherapy BIOLOGICAL

Autologous Tcm cells immunotherapy is to collect patient's own immune cells in peripheral blood and then given back to the patient after amplified in vitro.

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent for the study.
• Subjects with pathologically confirmed stage II NSCLC.
• Subjects with stage II NSCLC had treatment with surgical resection and 4 cycles of postoperative adjuvant chemotherapy before the study.
• Karnofsky (KPS) ≥ 60.
• One or more Serum tumor markers such as carcinoembryonic antigen (CEA), CA125, cytokeratin-19 fragment (CYFRA21-1), neuron-specific enolase (NSE), pro-grp and angiopoietin-2 (Ang-2) are double higher than normal level or durative elevator on three consecutive tests.
• Adequate hematologic and end-organ function.
• Subjects who could receive treatment with at least 3 cycles of autologous Tcm cells immunotherapy.
• Subjects must be received auxiliary examination and record these results in detail before and after immunotherapy.
• Subjects must meet the indications for autologous Tcm cells immunotherapy.

You may not qualify if:

• Subjects with lung nodules, lymph nodes, brain, liver, bone or adrenal metastasis before the study.
• Subjects who are using immunosuppressive agents or long-term immunosuppressive agents after organ transplantation.
• Subjects with severe abnormality of coagulation.
• History or any evidence of hemorrhage.
• Subjects with severe infection or high fever.
• Subjects with severe autoimmune diseases.
• Subjects with persistent or intractable epilepsy.
• Subjects with merging other malignant neoplasms.
• Subjects with mental disorder.
• Subjects with heart, liver or kidney diseases.
• Major surgeries except for surgical resection of NSCLC were performed in 4 weeks before the study.
• Autologous bone marrow transplantation (ABMT) in 4 weeks before the study.
• Concurrent treatment or treatment on another study in 4 weeks before the study.
• Pregnancy or breast-feeding.
• There are drug abuse, medical treatment, mental illness and social disorders that would interfere with subjects' participation, or confound the results of the trial.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Newish Technology (Beijing) Co., Ltd.: collaborator

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jing Wang

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Wang

CONTACT

+86-13801334518; wj7339@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant director physician

Model Details: Experimental group: immunotherapy. subjects who are treated with autologous Tcm cells immunotherapy. No intervention group: subjects who are treated without autologous Tcm cells immunotherapy.

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 14, 2018
• Study Start: April 3, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)