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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusion

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 The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study.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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qiyun Sun; Phone Number: +8613651058454; Email: 13651058454@139.com
• Study Contact Backup: Name: Yong Da; Phone Number: 8613466665939; Email: 15811031508@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Fengtai You'anmen Hospital
      • Contact: Yong Da

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients are 18-80 years old, regardless of gender or race;
• Advanced / relapsed solid tumors (small cell lung cancer, ovarian cancer, cervical cancer, gastric and colorectal cancer, sarcoma, head and neck tumor, etc.) are 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MST; standard chemotherapy with microtransplantation	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); Other Names: DSI
No Intervention: CT; standard chemotherapy only, without microtransplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of hematopoietic recovery	Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL	1 month
Treatment-Emergent Adverse Events	Treatment related mortality	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate	(markedly effective + effective) / number of patients × 100%	1year

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Investigators: Principal Investigator: Yong Da, Department of Medical Oncology, Beijing Fengtai You'anmen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: May 30, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: microtransplantation
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MST-ST-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No