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

Primary Purpose

Malignant Ascites

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Erythrocytes derived MPs containing MTX

convention drugs

About this trial

This is an interventional treatment trial for Malignant Ascites focused on measuring Microparticles, Erythrocytes, Methotrexate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hui ting XuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Erythrocytes derived MPs containing MTX

convention drugs

Arm Description

Suspension of erythrocytes derived MPs containing MTX, qd×6, 6 units MPs a time , Two courses.

Chemotherapeutic drugs, biologicals or traditional Chinese medicine.Dosage form, dosage, frequency and duration according to respective medicine instructions.

Outcomes

Primary Outcome Measures

ORR, Objective Response Rate

The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT03230708

First Posted

July 24, 2017

Last Updated

July 25, 2017

Sponsor

Hui ting Xu，MD

1. Study Identification

Unique Protocol Identification Number

NCT03230708

Brief Title

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

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2017 (Actual)

Primary Completion Date

December 1, 2017 (Anticipated)

Study Completion Date

February 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hui ting Xu，MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Ascites

Keywords

Microparticles, Erythrocytes, Methotrexate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Erythrocytes derived MPs containing MTX

Arm Type

Experimental

Arm Description

Suspension of erythrocytes derived MPs containing MTX, qd×6, 6 units MPs a time , Two courses.

Arm Title

convention drugs

Arm Type

Active Comparator

Arm Description

Chemotherapeutic drugs, biologicals or traditional Chinese medicine.Dosage form, dosage, frequency and duration according to respective medicine instructions.

Intervention Type

Other

Intervention Name(s)

Erythrocytes derived MPs containing MTX

Other Intervention Name(s)

Systemic therapy

Intervention Description

General conventional treatment and peritoneal drainage, additional peritoneal perfusion with erythrocytes derived MPs containing MTX

Intervention Type

Drug

Intervention Name(s)

convention drugs

Other Intervention Name(s)

Systemic therapy

Intervention Description

according to usage method of drugs

Primary Outcome Measure Information:

Title

ORR, Objective Response Rate

Description

The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)

Time Frame

From assignment of the first subject to 2 months later after the last participant is recruited.

Secondary Outcome Measure Information:

Title

DCR, Disease Control Rate

Description

Time Frame

From assignment of the first subject to 2 months later after the last participant is recruited.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hui ting Xu

Phone

15307176219

Ext

2891533@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hong li Xu

Phone

13554458191

xu2010ky@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yan li Nie, MD

Organizational Affiliation

Hu bei CH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hui ting Xu

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

027

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hui ting Xu, MD

Phone

15307176219

Ext

2891533@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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