NCT04937842

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2021

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

May 30, 2021

Last Update Submit

June 16, 2021

Conditions

Solid Tumors

Keywords

microtransplantation

Outcome Measures

Primary Outcomes (2)

  • Treatment-Emergent Adverse Events

    Treatment related mortality

    1 month

  • time of hematopoietic recovery

    Absolute neutrophil count \>500/mcL; Platelets ≥20,000/mcL

    1 month

Secondary Outcomes (1)

  • overall response rate

    1year

Study Arms (2)

MST

EXPERIMENTAL

standard chemotherapy with microtransplantation

Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusion

CT

NO INTERVENTION

standard chemotherapy only, without microtransplantation

Interventions

microtransplantation, HLA-mismatched donor peripheral stem cell infusionBIOLOGICAL

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

Also known as: DSI
MST

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • have no suitable donor or donor refused
  • patient refused to accept donor cells

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Fengtai You'anmen Hospital

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

  • Yong Da

    Department of Medical Oncology, Beijing Fengtai You'anmen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Da

CONTACT

861346666593915811031508@163.com

Qiyun Sun

CONTACT

+861365105845413651058454@139.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

May 30, 2021

First Posted

June 24, 2021

Study Start

June 1, 2021

Primary Completion

May 31, 2023

Study Completion

June 1, 2025

Last Updated

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)