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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05095558
Other study ID # MST-OC-2021
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 1, 2021
Est. completion date October 1, 2025

Study information

Verified date October 2021
Source The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Contact WEIPING LI
Phone +8615811031508
Email 15811031508@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, we will apply micro transplantation to the field of recurrent and advanced ovarian cancer to study the efficacy and safety.


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 The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study.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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 1, 2025
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Biological:
microtransplantation, HLA-mismatched donor peripheral stem cell infusion
infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)

Locations

Country Name City State
China The third medical center of PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment-Emergent Adverse Events Treatment related mortality 1 month
Primary time of hematopoietic recovery Absolute neutrophil count >500/mcL; Platelets =20,000/mcL 1 month
Secondary overall response rate (markedly effective + effective) / number of patients × 100% 1year
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