Back to resultsMicrotransplantation for Ovarian Cancer
Primary Purpose
Ovarian Cancer Recurrent
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
microtransplantation, HLA-mismatched donor peripheral stem cell infusion
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer Recurrent focused on measuring microtransplantation
Eligibility Criteria
Inclusion Criteria:
- Patients are 18-80 years old, female，regardless of race;
- Advanced / relapsed ovarian cancer confirmed by clinical or histopathological diagnosis;
- More than two kinds of tumors are allowed;
- Karnofsky score ≥ 60, ECoG physical status ≤ 2;
- Sensitive to chemotherapy or radiotherapy;
- There are measurable lesions;
- There are suitable hematopoietic stem cell donors
Exclusion Criteria:
- have no suitable donor or donor refused
- patient refused to accept donor cells
Sites / Locations
- The third medical center of PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MST
CT
Arm Description
standard chemotherapy with microtransplantation
standard chemotherapy only, without microtransplantation
Outcomes
Primary Outcome Measures
Treatment-Emergent Adverse Events
Treatment related mortality
time of hematopoietic recovery
Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL
Secondary Outcome Measures
overall response rate
(markedly effective + effective) / number of patients × 100%
Full Information
NCT ID
NCT05095558
First Posted
October 26, 2021
Last Updated
October 26, 2021
Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05095558
Brief Title
Microtransplantation for Ovarian Cancer
Official Title
Microtransplantation for Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In this study, we will apply micro transplantation to the field of recurrent and advanced ovarian cancer to study the efficacy and safety.
Detailed Description
The eligible patients are assigned to the experimental group (microtransplantation group, MST group) or the control group (CT) according to the availability of suitable donors. In MST group, peripheral blood hematopoietic stem cells from HLA mismatched donors mobilized with granulocyte colony stimulating factor are infused after conventional chemotherapy and/or radiotherapy ; The CT group only received conventional chemotherapy and/or radiotherapy. According to the patient's past medical history, current tumor assessment results, and the latest cancer treatment guidelines, the individualized chemotherapy and / or radiotherapy plan for the patient is formulated after discussion by more than 3 oncologists. After each course of treatment, the efficacy and safety are evaluated. For the patients who are evaluated to be effective or stable (SD) after the first treatment, the second treatment of the same scheme will be given. Those who reach the disease control level will continue to be treated for 4 courses, with an interval of 28 days. The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study. Patients are allowed to receive any treatment, including symptomatic support treatment, after the end of treatment or withdrawal from the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer Recurrent
Keywords
microtransplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MST
Arm Type
Experimental
Arm Description
standard chemotherapy with microtransplantation
Arm Title
CT
Arm Type
No Intervention
Arm Description
standard chemotherapy only, without microtransplantation
Intervention Type
Biological
Intervention Name(s)
microtransplantation, HLA-mismatched donor peripheral stem cell infusion
Other Intervention Name(s)
DSI
Intervention Description
infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)
Primary Outcome Measure Information:
Title
Treatment-Emergent Adverse Events
Description
Treatment related mortality
Time Frame
1 month
Title
time of hematopoietic recovery
Description
Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL
Time Frame
1 month
Secondary Outcome Measure Information:
Title
overall response rate
Description
(markedly effective + effective) / number of patients × 100%
Time Frame
1year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients are 18-80 years old, female，regardless of race;
Advanced / relapsed ovarian cancer confirmed by clinical or histopathological diagnosis;
More than two kinds of tumors are allowed;
Karnofsky score ≥ 60, ECoG physical status ≤ 2;
Sensitive to chemotherapy or radiotherapy;
There are measurable lesions;
There are suitable hematopoietic stem cell donors
Exclusion Criteria:
have no suitable donor or donor refused
patient refused to accept donor cells
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WEIPING LI
Phone
+8615811031508
Email
15811031508@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
QIYUN Sun
Phone
+8613651058454
Email
13651058454@139.com
Facility Information:
Facility Name
The third medical center of PLA General Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiping Li
Phone
+8615811031508
Email
15811031508@163.com
12. IPD Sharing Statement
Learn more about this trial
Microtransplantation for Ovarian Cancer
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