Clinical Study of Autologous Erythrocytes Derived MPs Packaging MTX Peritoneal Perfusion to Treat Malignant Ascites
NCT ID: NCT03230708
Last Updated: 2017-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2017-05-01
2018-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Erythrocytes derived MPs containing MTX
Suspension of erythrocytes derived MPs containing MTX, qd×6, 6 units MPs a time , Two courses.
Erythrocytes derived MPs containing MTX
General conventional treatment and peritoneal drainage, additional peritoneal perfusion with erythrocytes derived MPs containing MTX
convention drugs
Chemotherapeutic drugs, biologicals or traditional Chinese medicine.Dosage form, dosage, frequency and duration according to respective medicine instructions.
convention drugs
according to usage method of drugs
Interventions
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Erythrocytes derived MPs containing MTX
General conventional treatment and peritoneal drainage, additional peritoneal perfusion with erythrocytes derived MPs containing MTX
convention drugs
according to usage method of drugs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Hui ting Xu，MD
OTHER
Responsible Party
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Hui ting Xu，MD
Deputy Chief Physician
Principal Investigators
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Yan li Nie, MD
Role: PRINCIPAL_INVESTIGATOR
Hu bei CH
Locations
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Hui ting Xu
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NP-FS-002
Identifier Type: -
Identifier Source: org_study_id
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