NCT02657460

Brief Summary

The study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion.

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
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Typical duration for phase_2

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

January 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

3.9 years

First QC Date

January 11, 2016

Last Update Submit

February 24, 2019

Conditions

Malignant Pleural Effusion

Keywords

chemotherapymicroparticlemalignant pleural effusion

Outcome Measures

Primary Outcomes (1)

  • Pleural effusions volume

    four weeks

Secondary Outcomes (13)

  • Rivalta Test of pleural effusions

    four weeks

  • total protein level of pleural effusions

    four weeks

  • total karyocytes count of pleural effusions

    four weeks

  • lactic dehydrogenase level of pleural effusions

    four weeks

  • adenosine deaminase level of pleural effusions

    four weeks

  • +8 more secondary outcomes

Study Arms (2)

MTX-ATMPs

EXPERIMENTAL

methotrexate-autologous tumor derived microparticles

Biological: tumor derived microparticles

cisplatin

SHAM COMPARATOR

Cisplatin is a traditional treatment for lung cancer

Drug: cisplatin

Interventions

tumor derived microparticlesBIOLOGICAL

The main difference between the two treatment groups is the biological coat, which is tumor derived microparticles.

MTX-ATMPs
cisplatinDRUG

cisplatin is a traditional drug for lung cancer

Also known as: cisplatinum
cisplatin

Eligibility Criteria

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

You may qualify if:

  • The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology and / or pleural fluid cytology;
  • The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed, or routine treatment therapy was given up by self-causes;
  • stable vital sign with KPS(Karnofsky Performance Status) index more than 60;
  • years old;
  • normal haematopoietic function of bone marrow, no hemorrhagic tendency, blood routine test: HGB\>=100g/L, WBC\>4.0\*10\^9/L, PLT\>80\*10\^9/L, serum ALT, AST within 2 times upper limit of normal, BUN within 1.5 time upper limit of normal, creatinine within normal range, normal EKG;
  • agreed to participate in the study and sign an informed consent;
  • without other severe comorbidities.

You may not qualify if:

  • lactating or pregnant patients;
  • allergy to multiple drugs;
  • with other severe comorbidities or psychological diseases;
  • severe infection;
  • participation in other clinical trials within the recent three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Yang Jin, doctor

    Union Hospital, Tongji Medical College, Huazhong University of Science & Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Wu, Master

CONTACT

086-13476080943wufengxiehe@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 15, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

no plan to share IPD now

Locations

CN(1)