Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion

NCT ID: NCT02657460

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-12-31

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.

Detailed Description

Malignant pleural effusion(MPE) as a common complication of advanced lung cancer is lack of efficient treatments. The investigators have successfully produced tumor cell-derived microparticles packaging chemotherapy drugs and confirmed that this new integrative targeted biochemotherapy treatment could effectively restrain tumor growth at cellular and animal levels.This new method could control tumor growth in vivo effectively and induced pleural adhesion in the early clinical study. So the investigators attempt to explore the anticancer effect and related immune regulation mechanism of methotrexate-autologous tumor derived microparticles (MTX-ATMPs) in MPE treatment. The tumor cells in the malignant pleural effusion are prepared by screening, then MTX-ATMPs are made. Participants enrolled are randomly assigned to experimental and control group, each of them is injected with the prepared drug once in two days until the malignant pleural effusion are disappeared or the treatment cycle has been six times. During or after the whole treatment, reactions to each treatment of the participants are carefully followed up.

Conditions

Malignant Pleural Effusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MTX-ATMPs

methotrexate-autologous tumor derived microparticles

Group Type: EXPERIMENTAL

tumor derived microparticles

Intervention Type: BIOLOGICAL

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

cisplatin

Cisplatin is a traditional treatment for lung cancer

Group Type: SHAM_COMPARATOR

cisplatin

Intervention Type: DRUG

cisplatin is a traditional drug for lung cancer

Interventions

tumor derived microparticles

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

Intervention Type: BIOLOGICAL

cisplatin

cisplatin is a traditional drug for lung cancer

Intervention Type: DRUG

Other Intervention Names

cisplatinum

Eligibility Criteria

Inclusion Criteria

1. The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology and / or pleural fluid cytology;

2. The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed, or routine treatment therapy was given up by self-causes;

3. stable vital sign with KPS(Karnofsky Performance Status) index more than 60;

4. 18-70 years old;

5. 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;

6. agreed to participate in the study and sign an informed consent;

7. without other severe comorbidities.

Exclusion Criteria

1. lactating or pregnant patients;

2. allergy to multiple drugs;

3. with other severe comorbidities or psychological diseases;

4. severe infection;

5. participation in other clinical trials within the recent three months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Yang Jin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yang Jin, doctor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Wu, Master

Role: CONTACT

wufengxiehe@163.com

086-13476080943

Facility Contacts

Yang Jin, doctor

Role: primary

whuhjy@sina.com

+86 13554361146

Other Identifiers

v1.4

Identifier Type: -

Identifier Source: org_study_id