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This study makes an observation over the objective response rate of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination in the treatment of malignant ascites. All the participants will randomly receive the treatment of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination or convention drugs peritoneal perfusion and systemic therapy combination.
As a drug carrier, erythrocytes have their own advantages, such as high biocompatibility, high immune compatibility, simple structure and easy access. In this study, microparticles released from erythrocytes are used as the carrier of chemotherapy drugs and effectively kill tumor cells in malignant ascites. These microparticles can easily reach the tumor site and bring the drug into tumor cells, which can overcome the two main problems in normal chemotherapy: damage to normal cells and drug resistance of tumor cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythrocytes derived MPs containing MTX | Experimental | Suspension of erythrocytes derived MPs containing MTX, qd×6, 6 units MPs a time , Two courses. |
|
| convention drugs | Active Comparator | Chemotherapeutic drugs, biologicals or traditional Chinese medicine.Dosage form, dosage, frequency and duration according to respective medicine instructions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythrocytes derived MPs containing MTX | Other | General conventional treatment and peritoneal drainage, additional peritoneal perfusion with erythrocytes derived MPs containing MTX |
| Measure | Description | Time Frame |
|---|---|---|
| ORR, Objective Response Rate | The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR) | From assignment of the first subject to 2 months later after the last participant is recruited. |
| Measure | Description | Time Frame |
|---|---|---|
| DCR, Disease Control Rate | DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD) | From assignment of the first subject to 2 months later after the last participant is recruited. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui ting Xu | Contact | 15307176219 | 86 | 2891533@qq.com |
| Hong li Xu | Contact | 13554458191 | xu2010ky@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan li Nie, MD | Hu bei CH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hui ting Xu | Recruiting | Wuhan | Hubei | 027 | China |
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| convention drugs | Drug | according to usage method of drugs |
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