MedDataX Logo

Microtransplantation for Ovarian Cancer

NCT ID: NCT05095558

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2025-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study.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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer Recurrent

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

microtransplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MST

standard chemotherapy with microtransplantation

Group Type EXPERIMENTAL

microtransplantation, HLA-mismatched donor peripheral stem cell infusion

Intervention Type BIOLOGICAL

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

CT

standard chemotherapy only, without microtransplantation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

microtransplantation, HLA-mismatched donor peripheral stem cell infusion

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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DSI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The third medical center of PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

WEIPING LI

Role: CONTACT

Phone: +8615811031508

Email: [email protected]

QIYUN Sun

Role: CONTACT

Phone: +8613651058454

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Weiping Li

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MST-OC-2021

Identifier Type: -

Identifier Source: org_study_id