This trial was designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by trans-artery/intra-tumor infusion of PD1/PDL1 antibody and/or CTLA4 antibody ipilimumab plus chemotherapeutic drug and to compare their differences.
Cytohistological confirmation is required for diagnosis of cancer.
Signed informed consent before recruiting.
Age above 18 years with estimated survival over 3 months.
Child-Pugh class A or B/Child score > 7; ECOG score < 2
Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
Patients accompanied with other tumors or past medical history of malignancy;
Parallel
Checkpoint inhibitor (CPI) such as Pembrolizumab plus chemotherapy
Drugvein, artery, or intra-tumor infusion of checkpoint inhibitor (CPI) such as Pembrolizumab and/or Ipilimumab, plus chemotherapy to destroy cancer cells and release tumor antigen for improving CPI therapeutic efficacy.
Overall survival
Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.
Complete response (CR) rate before or at Month 6
Percentage of patients achieving complete response (CR) before or at Month 6
Progression-free survival
Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per mRECIST) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
Duration of remission (DOR)
DOR will be defined as the duration of the cancer remission
Disease control rate
Disease control rate will be defined as objective response rate + steady disease rate.
Cause of death (COD) when appropriate
Cause of death (COD) when appropriate
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