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

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ClinicalTrials.gov Identifier: NCT03230708
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Hui ting Xu,MD, Hubei Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Malignant Ascites Other: Erythrocytes derived MPs containing MTX Drug: convention drugs Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Trial Study on Autologous Erythrocytes Derived Microparticles Packaging Methotrexate Peritoneal Perfusion in the Treatment of Malignant Ascites
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : February 1, 2018

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 Name: 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 Name: Systemic therapy




Primary Outcome Measures :
  1. ORR, Objective Response Rate [ Time Frame: From assignment of the first subject to 2 months later after the last participant is recruited. ]
    The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)


Secondary Outcome Measures :
  1. DCR, Disease Control Rate [ Time Frame: From assignment of the first subject to 2 months later after the last participant is recruited. ]
    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)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230708


Contacts
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Contact: Hui ting Xu 15307176219 ext 86 2891533@qq.com
Contact: Hong li Xu 13554458191 xu2010ky@163.com

Locations
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China, Hubei
Hui ting Xu Recruiting
Wuhan, Hubei, China, 027
Contact: Hui ting Xu, MD    15307176219 ext 86    2891533@qq.com   
Sponsors and Collaborators
Hui ting Xu,MD
Investigators
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Principal Investigator: Yan li Nie, MD Hu bei CH

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Responsible Party: Hui ting Xu,MD, Deputy Chief Physician, Hubei Cancer Hospital
ClinicalTrials.gov Identifier: NCT03230708     History of Changes
Other Study ID Numbers: NP-FS-002
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hui ting Xu,MD, Hubei Cancer Hospital:
Microparticles
Erythrocytes
Methotrexate

Additional relevant MeSH terms:
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Ascites
Pathologic Processes
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors