Microtransplantation for Advanced and Relapsed Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-06-01

Brief Summary

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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.

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Detailed Description

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 The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study.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

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MST

standard chemotherapy with microtransplantation

Group Type EXPERIMENTAL

microtransplantation, HLA-mismatched donor peripheral stem cell infusion

Intervention Type BIOLOGICAL

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

CT

standard chemotherapy only, without microtransplantation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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microtransplantation, HLA-mismatched donor peripheral stem cell infusion

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

Intervention Type BIOLOGICAL

Other Intervention Names

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DSI

Eligibility Criteria

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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