NCT05095558

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2021

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

2.1 years

First QC Date

October 26, 2021

Last Update Submit

October 26, 2021

Conditions

Ovarian Cancer Recurrent

Keywords

microtransplantation

Outcome Measures

Primary Outcomes (2)

  • Treatment-Emergent Adverse Events

    Treatment related mortality

    1 month

  • time of hematopoietic recovery

    Absolute neutrophil count \>500/mcL; Platelets ≥20,000/mcL

    1 month

Secondary Outcomes (1)

  • overall response rate

    1year

Study Arms (2)

MST

EXPERIMENTAL

standard chemotherapy with microtransplantation

Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusion

CT

NO INTERVENTION

standard chemotherapy only, without microtransplantation

Interventions

microtransplantation, HLA-mismatched donor peripheral stem cell infusionBIOLOGICAL

infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)

Also known as: DSI
MST

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • have no suitable donor or donor refused
  • patient refused to accept donor cells

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The third medical center of PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

WEIPING LI

CONTACT

+861581103150815811031508@163.com

QIYUN Sun

CONTACT

+861365105845413651058454@139.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2021

First Posted

October 27, 2021

Study Start

October 1, 2021

Primary Completion

October 31, 2023

Study Completion

October 1, 2025

Last Updated

October 27, 2021

Record last verified: 2021-10

Locations

CN(1)