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

Malignant Ascites Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03230708
• Other study ID #: NP-FS-002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 24, 2017
• Last updated: July 25, 2017
• Start date: May 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: July 2017
• Source: Hubei Cancer Hospital
• Contact: Hui ting Xu
• Phone: 15307176219
• Email: 2891533[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: February 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Malignant Ascites

Intervention

Other:
• Erythrocytes derived MPs containing MTX
General conventional treatment and peritoneal drainage, additional peritoneal perfusion with erythrocytes derived MPs containing MTX

Drug:
• convention drugs
according to usage method of drugs

Locations

Country	Name	City	State
China	Hui ting Xu	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Hui ting Xu,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.