Microtransplantation for Ovarian Cancer

Phase 1

Recruiting

• Conditions: Ovarian Cancer Recurrent
• Interventions: Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusion

• Registration Number: NCT05095558
• Lead Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

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 The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study.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

Study Timeline

• Status Verified: 2021-10
• Study Start: 2021-10-01
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-26
• Last Update Submitted: 2021-10-26
• Study First Posted: 2021-10-27
• Last Update Posted: 2021-10-27
• Primary Completion: 2023-10-31
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MST	microtransplantation, HLA-mismatched donor peripheral stem cell infusion	standard chemotherapy with microtransplantation

Primary Outcome Measures

Name	Time	Method
Treatment-Emergent Adverse Events	1 month	Treatment related mortality
time of hematopoietic recovery	1 month	Absolute neutrophil count \>500/mcL; Platelets ≥20,000/mcL

Secondary Outcome Measures

Name	Time	Method
overall response rate	1year	(markedly effective + effective) / number of patients × 100%

Trial Locations

Locations (1)

The third medical center of PLA General Hospital; 🇨🇳 Beijing, Beijing, China