Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study.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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MST | Experimental | standard chemotherapy with microtransplantation |
|
| CT | No Intervention | standard chemotherapy only, without microtransplantation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microtransplantation, HLA-mismatched donor peripheral stem cell infusion | Biological | infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | (markedly effective + effective) / number of patients × 100% | 1year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Da | Contact | 8613466665939 | 15811031508@163.com | |
| Qiyun Sun | Contact | +8613651058454 | 13651058454@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Yong Da | Department of Medical Oncology, Beijing Fengtai You'anmen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Fengtai You'anmen Hospital | Recruiting | Beijing | Beijing Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|