This is an open-label, single-arm, Phase II investigator-initiated trial of precise thymalfasin-regulated therapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF for treatment of advanced refractory solid tumors.
One cycle of activation cycle includes: Loading dose with thymalfasin was administrated based on the absolute number of T lymphocytes. Radiotherapy (5 or 8Gy three fractions)was administrated to a metastatic lesion. GM-CSF 200ug was subcutaneous injected for seven days from the first day of radiotherapy PD-1/L1 inhibitor was intravenous injected within one week after radiotherapy. At least two activation cycles were administrated. Then maintenance treatment includes: Loading dose with thymalfasin was administrated based on the absolute number of T lymphocytes. GM-CSF 200ug was subcutaneous injected for seven days. PD-1/L1 inhibitor was intravenous injected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
loading dose with thymalfasin based on the amounts of T lymphocyte
hypofractionated radiotherapy/SBRT
The PD-1/PD-L1 inhibitors are used within one week after radiotherapy
The Second Affiliated Hospital of SchoowUniversity
Suzhou, China
RECRUITINGOverall response rate (ORR)
ORR is defined as the proportion of patients who have a partial (PR) or complete response (CR) to therapy among the total number of evaluable patients.
Time frame: 24 months
Disease control rate (DCR)
the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD)
Time frame: 24 months
Progression free survival (PFS)
The time from commencement of treatment to disease progression or death from any cause.
Time frame: 24 months
Overall survival (OS)
The time from the first day of enrollment to death from any cause.
Time frame: 24 months
Incidence of adverse events
the rate of AE
Time frame: 24 months
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subcutaneous injection daily for 7 consecutive days