Clinical trial NCT03230708: Clinical Study of Autologous Erythrocytes Derived MPs Packaging MTX Peritoneal Perfusion to Treat Malignant Ascites
Official title: A Phase I/II Clinical Trial Study on Autologous Erythrocytes Derived Microparticles Packaging Methotrexate Peritoneal Perfusion in the Treatment of Malignant Ascites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Malignant Ascites
Keywords: Microparticles
Erythrocytes
Methotrexate
Lead sponsor: Hubei Cancer Hospital
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: ORR, Objective Response Rate
timeFrame: From assignment of the first subject to 2 months later after the last participant is recruited.
Secondary outcomes:
measure: DCR, Disease Control Rate
timeFrame: From assignment of the first subject to 2 months later after the last participant is recruited.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hui ting Xu
state: Hubei
Study officials:
affiliation: Hu bei CH
name: Yan li Nie, MD
role: PRINCIPAL_INVESTIGATOR
References: