Microtransplantation for Advanced and Relapsed Solid Tumors

Study Overview
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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.

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 The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study.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

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

Conditions
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Solid Tumors

Intervention / Treatment
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* Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusion


Participation Criteria
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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 Exclusion Criteria: have no suitable donor or donor refused patient refused to accept donor cells

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MST<br>standard chemotherapy with microtransplantation | Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusion<br>* infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)<br>* Other names: DSI;|
| No Intervention: CT<br>standard chemotherapy only, without microtransplantation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microtransplantation