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This is a prospective, open-label , multicenter randomized controlled trial, with 248 cases in 50 centers planned for a period of 2 years. The aim of the study is to evaluate the safety and effectiveness of microparticles packaging chemotherapeutic drugs (MPCD) therapy on the treatment of malignant pleural effusion (MPE) in patients with advanced lung cancer or breast cancer.
After obtaining informed consent, patients who meet the eligibility criteria will be randomly assigned 1:1 to treatment either with MPCD or recombinant human interleukin-2(rhIL-2) for injection. Randomization is stratified by tumor type and previous treatment. Patients in the MPCD group are first treated with microparticles packaging methotrexate (MPs-MTX) via intrapleural infusion four times on day5,6,7,8 and then undergo chemotherapy 1 cycle from day12. Patients in the control group are first treated with rhIL-2 via intrapleural infusion three times on day5,8,11 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), the efficacy is assessed according to the WHO (1997) Response Evaluation Criteria In MPE and the evaluation methods mainly include physical examination, ultrasound and computed tomography (CT). The patients will be monitored by telephone every three months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| microparticles packaging methotrexate (MPs-MTX) group | Experimental | Patients are first treated with microparticles packaging methotrexate (MPs-MTX) via intrapleural infusion four times on day5,6,7,8 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), ORR is assessed. MPs-MTX: 5 U of MPs-MTX containing a total dose of more than 25μg of MTX dissolving in 50ml of physiological saline solution |
|
| recombinant human interleukin-2(rhIL-2) group | Active Comparator | Patients are first treated with rhIL-2 via intrapleural infusion three times on day5,8,11 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), ORR is assessed. rhIL-2: 2 million IU of rhIL-2 dissolving in 50ml of physiological saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microparticles packaging methotrexate (MPs-MTX) | Drug | 50ml, intrapleural infusion, day5,6,7,8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Percentage of patients whose pleural effusion completely recover or reduce by more than 50% for more than 4 weeks | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Time from the date of first receive treatment to the date of first documented progression or date of death from any cause whichever came first | up to 20 months |
| Overall Survival(OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Ma, MD | Contact | 8613910217780 | drmafei@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Fei Ma, MD | Cancer Hospital Chinese Academy of Medical Science | Principal Investigator |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| recombinant human interleukin-2(rhIL-2) | Drug | 50ml, intrapleural infusion, day5,8,11 |
|
Time from the date of first receive treatment to the date of death
| up to 20 months |
| Level of tumor markers | The change of the level of tumor markers(CEA,CA125) in blood and pleural effusion before and after treatment | up to 20 months |
| Index of pleural effusion | Routine, biochemistry and cytological examination of pleural effusion | up to 20 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010997 | Pleural Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |