Advanced and Relapsed Solid Tumors
Conditions
Keywords
microtransplantation, solid tumors
Brief summary
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
BIOLOGICALMST
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)
Sponsors
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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；
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Emergent Adverse Events | 1 month | Treatment related mortality |
| time of hematopoietic recovery | 1 month | Absolute neutrophil count \>500/μL; Platelets ≥20,000/μL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate, DCR | 1 year | (markedly effective + effective + stable disease) / number of patients × 100% |
Countries
China
Contacts
CONTACTXiang Lu, Professor
PRINCIPAL_INVESTIGATORXiang Lu, Professor
The First People's Hospital of Nanning
PRINCIPAL_INVESTIGATORhuiqin Wei, Professor
Minzu Hospital of Guangxi Zhuang Autonomous Region
PRINCIPAL_INVESTIGATORyajing Huang, Professor
Innovvy(Beijing) Biomedical Technology Co., Ltd
Outcome results
None listed