NCT04937842

Microtransplantation for Advanced and Relapsed Solid Tumors

Efficacy and Safety of Radiotherapy or Chemotherapy Combined With Microtransplantation in the Treatment of Advanced and Relapsed Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this study, we will apply micro transplantation to the field of solid tumors to study the efficacy and safety of radiotherapy and chemotherapy combined with micro transplantation in the treatment of advanced / relapsed solid tumors.

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 The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study.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

Conditions

• Solid Tumors

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-05-31
• Completion: 2025-06-01
• First posted: 2021-06-24
• Last updated: 2021-06-24

Locations

1 site across 1 country: China