This is a multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent / refractory pleural mesothelioma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Cadonilimab (15mg/kg, intravenous drip, D1) + gemcitabine (1250mg/m2, intravenous drip, D1/D8) or vinorelbine (30mg, oral, tiw, D1/D3/D5) or pemetrexed (500mg/m2, intravenous drip, D1), every 3 weeks.
Objective Response Rate (ORR)
defined as the percentage of participants who achieve a best overall response of complete response or partial response assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
Time frame: 2 year
Disease Control Rate (DCR)
defined as the percentage of participants who achieve a best overall response of complete response, partial response, or stable disease assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
Time frame: 2 year
Progression Free Survival (PFS)
defined as the time between the date of first dose of study drug and the date of first documented tumor progression per mRECIST v1.1, or death due to any cause, whichever occurs first.
Time frame: 2 year
Duration of Response (DoR)
defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented tumor progression, or death due to any cause, whichever occurs first.
Time frame: 2 year
Overall Survival (OS)
defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented tumor progression, or death due to any cause, whichever occurs first.
Time frame: 2 year
Adverse Events (AEs)
Incidence and severity of adverse events (AE) and clinically significant abnormal laboratory results
Time frame: 2 year
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