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

NCT03230708 | Unknown Phase 1

• 1 other identifier: NP-FS-002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Ascites

Keywords

Microparticles; Erythrocytes; Methotrexate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• DCR, Disease Control Rate

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

Study Arms (2)

Erythrocytes derived MPs containing MTX

EXPERIMENTAL

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

Other: Erythrocytes derived MPs containing MTX

convention drugs

ACTIVE COMPARATOR

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

Drug: convention drugs

Interventions

Erythrocytes derived MPs containing MTX OTHER

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

Also known as: Systemic therapy

Erythrocytes derived MPs containing MTX

convention drugs DRUG

according to usage method of drugs

Also known as: Systemic therapy

convention drugs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hui ting Xu，MD: lead

Study Sites (1)

Hui ting Xu

Wuhan, Hubei, 027, China

RECRUITING

Study Officials

• Yan li Nie, MD

  Hu bei CH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui ting Xu

CONTACT

15307176219; 2891533@qq.com

Hong li Xu

CONTACT

13554458191; xu2010ky@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: May 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: July 26, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)