Microtransplantation for Ovarian Cancer

Ovarian Cancer Recurrent Clinical Trial

Official title:

Microtransplantation for Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05095558
• Other study ID #: MST-OC-2021
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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 The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study.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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer Recurrent
• Ovarian Neoplasms

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