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In this study, microtransplantation (MST) will be administrated to patients diagnosed with advanced / relapsed solid tumors to assess the therapeutic efficacy and safety of conventional chemotherapy in combination with MST for the treatment of advanced/relapsed solid tumors.
In this study, the eligible patients will receive MST treatment following conventional chemotherapy, MST is the infusion of G-PBMCs after chemotherapy. G-PBMCs are peripheral blood mononuclear cells from HLA mismatched unrelated donors mobilized by granulocyte colony-stimulating factor (G-CSF).
Based on the patient's medical history, current tumor assessment results, and the latest cancer treatment guidelines, an individualized chemotherapy plan for the patient is formulated through discussions among more than three oncologists. After each course of treatment, all relevant indicators, including efficacy and safety measures are evaluated.
Patients will receive all treatment for four courses, with an interval of 21 to 28 days. After completing all the treatment courses, the patient will enter the evaluation stage. Patients who have entered the evaluation stage are permitted to receive any treatments, including symptomatic support treatment, after the completion of treatment or withdrawal from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| microtransplantation; MST | Experimental | conventional chemotherapy with microtransplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MST | Biological | conventional chemotherapy with microtransplantation(MST). Microtransplantation, which is the infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood mononuclear cells (GPBMC) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emergent Adverse Events | Treatment related mortality | 1 month |
| time of hematopoietic recovery | Absolute neutrophil count >500/μL; Platelets ≥20,000/μL | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate, DCR | (markedly effective + effective + stable disease) / number of patients × 100% | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Lu, Professor | Contact | 86-18077107296 | 2584779171@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiang Lu, Professor | The First People's Hospital of Nanning | Principal Investigator |
| huiqin Wei, Professor | Minzu Hospital of Guangxi Zhuang Autonomous Region | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovvy(Beijing) Biomedical Technology Co., Ltd | Haidian | Beijing Municipality | China |
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| yajing Huang, Professor |
| Innovvy(Beijing) Biomedical Technology Co., Ltd |
| Principal Investigator |
| Minzu Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | China |
|
| The First People's Hospital of Nanning | Nanning | Guangxi | China |
|