This is an open-label, single-arm, Phase II investigator-initiated trial of hypofractionated radiotherapy combined with PD-L1 inhibitor sequential GM-CSF and thymopentin for treatment of elderly patients with advanced solid tumors, when the HER-2 positive patients are treated with extra antibody-drug conjugate.
Aged 75 years and above
Standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant solid tumor patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy
ECOG(Eastern Cooperative Oncology Group) performance is 0-3
Life expectancy greater than 3 months
Current pregnancy or lactation
History of other malignant tumors within 5 years prior to dose administration, expect for#malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer)
Uncontrolled epilepsy, central nervous system diseases or mental illness
arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study
Single group
ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin
DrugRC48-ADC combined with hypofractionated radiotherapy, PD-L1 inhibitor sequential GM- CSF and Thymopentin
Objective Response Rate #ORR#
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
Progression-free Survival (PFS)
PFS was defined as the time from the first administration of study treatment to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever comes first.
Disease control rate (DCR)
DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD).
Overall survival (OS)
OS was defined as the time from the first administration of study treatment to death from any cause.
Adverse event
rate of adverse events
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