Microtransplantation for Advanced and Relapsed Solid Tumors

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    60
  • sponsor
    The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Updated on 1 July 2021

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.

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 The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study.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

Details
Condition Solid Neoplasm, Solid Tumour, Solid Tumors
Treatment microtransplantation, HLA-mismatched donor peripheral stem cell infusion
Clinical Study IdentifierNCT04937842
SponsorThe Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Last Modified on1 July 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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