This is a single arm, open-label, non-randomized and single-center phase II clinical study, to evaluate the safety, tolerance, and efficacy of Camrelizumab in combination with Apatinib in patients with Radioactive Iodine-refractory Differentiated Thyroid Cancer (RAIR-DTC).
It is estimated that 10 patients who met the study criteria will be enrolled in 1 years and treated with Camrelizumab plus Apatinib in PUMCH. The investigators will follow up and collect subjects' data to evaluate the efficacy and safety of treatment, including objective response rate (ORR) and Progression-free Survival (PFS) and Overall Survival (OS), until disease progression or death.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Apatinib (250mg p.o. q.d.) combined with Camrelizumab (200mg, iv, q2w)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Objective Response Rate (ORR)
Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.
Time frame: Time Frame: two years
Overall Survival (OS)
Duration from the date of initial treatment to the date of death due to any cause.
Time frame: two years
Progression-free Survival (PFS)
A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause.
Time frame: two year
Disease Control Rate (DCR)
Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
Time frame: two year
Duration of Response (DoR)
Duration from the first time reported partial response or complete response to the first time of disease progression or death.
Time frame: two year
Time to Progression (TTP)
A duration from the date of initial treatment to disease progression (defined by RECIST 1.1)
Time frame: two year
Adverse events (AE)
Any adverse events related with treatment drugs and details include adverse events type, frequency and severity.
Time frame: two years
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