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

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

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.

Study Overview

• Status: Unknown
• Conditions: Malignant Ascites
• Intervention / Treatment: Other: Erythrocytes derived MPs containing MTX; Drug: convention drugs

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.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 027
      • Recruiting
      • Hui ting Xu
      • Contact: Hui ting XU, MD; Phone Number: 86 15307176219; Email: 2891533@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Hui ting Xu，MD
• Investigators: Principal Investigator: Yan li Nie, MD, Hu bei CH

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Methotrexate; Microparticles; Erythrocytes
• Additional Relevant MeSH Terms: Pathologic Processes; Ascites
• Other Study ID Numbers: NP-FS-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No