Efficacy and Safety of Microtransplantation for Advanced and Relapsed Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MST.
- Who it may be relevant to
- Registry conditions: Advanced and Relapsed Solid Tumors. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Biological MST
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)
Primary outcome measures
- Treatment-Emergent Adverse Events [Time frame: 1 month]
- time of hematopoietic recovery [Time frame: 1 month]
Secondary outcome measures (1)
- Disease Control Rate, DCR [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Patients are 18 to 90 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 ≥ 40, ECoG physical status ≤ 3;
- There are measurable lesions;
Exclusion criteria
- The researchers considered patients who were not suitable to participate in this experiment；
- Patients with mental disorders；
- Patients who refuse to cooperate with the treatment；
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Innovvy(Beijing) Biomedical Technology Co., Ltd — Haidian
- Minzu Hospital of Guangxi Zhuang Autonomous Region — Nanning
- The First People's Hospital of Nanning — Nanning
Identifiers
NCT: NCT07356856 · MST-ST-02