This study is a prospective, single arm phase II clinical trial ,aimed at exploring the efficacy and safety of the combination therapy of anti-PD-1 and VEGF bispecific antibody Ivonescimab combined with chemotherapy as first-line treatment of relapsed or metastatic thymic cancer.
This study is a prospective, single arm phase II clinical trial ,aimed at exploring the efficacy and safety of the combination therapy of anti-PD-1 and VEGF bispecific antibody Ivonescimab combined with chemotherapy as first-line treatment of relapsed or metastatic thymic cancer. Patients who met the inclusion criteria and were pathologically confirmed to be metastatic or recurrent thymic cancer were treated with first-line treatment of Ivonescimab (20mg/kg) combined with chemotherapy (carboplatin and paclitaxel / albumin paclitaxel), and the efficacy was evaluated clinically and radiologically. The primary endpoint of this study was the 6-month progression free survival rate (PFS6m), and the secondary endpoints included PFS, objective response rate (ORR), disease control rate (DCR), duration of remission (DOR), and overall survival (OS), as well as safety related research indicators including adverse events (AE) and quality of life score (QOL). During the study, biological samples were collected from patients, and exploratory studies on the efficacy and side effect biological markers of Ivonescimab were carried out.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Ivonescimab injection is an IgG1 subtype humanized bispecific antibody targeting human vascular endothelial growth factor-A (VEGF-A) and programmed death protein-1 (PD-1). It can bind to VEGF-A and PD-1 at the same time, and competitively block the interaction between VEGF-A, PD-1 and their ligands, exerting antitumor activity.
Progression free survival at 6 months(PFS 6m)
Patients who did not achieve PFS at 6 months accounted for the proportion of all patients.
Time frame: Within one year after starting treatment.
Progression free survival (PFS)
The time interval from the first dose of study medication to the first record of disease progression or death from any cause, whichever occurred first.
Time frame: Within two year after the first treatment
Objective response rate(ORR)
ORR, per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
Time frame: Within one year after starting treatment.
Disease control rate (DCR)
The proportion of subjects who achieved the best total efficacy was to confirm CR or PR or SD (according to iRECIST).
Time frame: Within one year after starting treatment.
duration of remission (DOR)
The time from the first record of confirmed remission (CR or PR) to the first record of disease progression (according to irecist) or death due to any cause, whichever occurs first.
Time frame: Within one year after starting treatment.
Overall survival (OS)
OS is defined as the time from the first administration of the study drug until the date of death from any cause. For subjects who are alive at the data cutoff, censoring will occur at the last known date of survival. Subjects with no follow-up information provided will be censored on the date of enrollment.
Time frame: Assessed from enrollment to death or last known survival, up to 4 years post-enrollment.
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