Clinical Study of Autologous Erythrocytes Derived MPs Packaging MTX Peritoneal Perfusion to Treat Malignant Ascites

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I/II Clinical Trial Study on Autologous Erythrocytes Derived Microparticles Packaging Methotrexate Peritoneal Perfusion in the Treatment of Malignant Ascites

Conditions
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Malignant Ascites

Intervention / Treatment
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* Other: Erythrocytes derived MPs containing MTX
* Drug: convention drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 and ≤ 80 years of age Histological confirmed gastric cancer, colorectal cancer, or ovarian cancer, tumor cells were detected by exfoliative cytology of peritoneal effusion, refractory or recurrent ascites of ovarian cancer were required, other kinds of cancer were not limited Vital signs were stable, Karnofsky ≥ 70, life expectancy of more than 3 months The hematopoietic function of bone marrow was normal without bleeding tendency (INR < 1.5), blood routine examination: HGB ≥ 90 g/L, WBC > 4.0 × 10^9/L (NEU ≥ 1.5 × 10^9/L), PLT ≥ 80 × 10^9/L Liver function: STB ≤ 1.5 ULN, AST and ALT≤ 2.5 ULN (if the abnormity of liver function was mainly caused by tumor invasion, AST and ALT ≤ 5 ULN), ALP ≤ 1.5 ULN Renal function: BUN and Cr ≤ 1.5 ULN, CCr ≥ 50mL/min ECG and blood glucose level were normal Patients or family members agreed to participate in the study and signed informed consent No other serious heart and lung disease, etc. Exclusion Criteria: Pregnant or lactating women Allergic constitution and multi-drug allergy Serious heart, lung, liver and kidney dysfunction, decompensated heart, lung, kidney, liver and other major organs dysfunction or failure, poor blood glucose control, chemotherapy intolerance, combined intestinal obstruction Concurrent severe infection HIV positive, HBsAg and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/mL), chronic hepatitis C blood screening positive (HCV antibody positive) Cognitive impairment or poor chemotherapy compliance determined by investigator Less than 4 weeks from the last clinical trial Unsuitable for clinical trials determined by investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erythrocytes derived MPs containing MTX<br>Suspension of erythrocytes derived MPs containing MTX, qd×6, 6 units MPs a time , Two courses. | Other: Erythrocytes derived MPs containing MTX<br>* General conventional treatment and peritoneal drainage, additional peritoneal perfusion with erythrocytes derived MPs containing MTX<br>* Other names: Systemic therapy;|
| Active Comparator: convention drugs<br>Chemotherapeutic drugs, biologicals or traditional Chinese medicine.Dosage form, dosage, frequency and duration according to respective medicine instructions. | Drug: convention drugs<br>* according to usage method of drugs<br>* Other names: Systemic therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microparticles, Erythrocytes, Methotrexate