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.
Untreated metastatic or recurrent inoperable thymic cancer patients at the initial stage; All patients need to undergo baseline PET/CT (or neck, chest, upper abdominal CT+cranial MR) for clinical staging.
The patient's age is ≥ 18 years old, with no gender restrictions.
Pathological diagnosis of thymic carcinoma through cytology/histology.
Expected survival period ≥ 3 months.
Patients with thymoma component suspected by pathological diagnosis (only thymic cancer patients were enrolled).
The patient has or is suspected of having autoimmune disease. Note: Patients with vitiligo, type I diabetes, or Hashimoto's thyroiditis who have hypothyroidism but only need hormone replacement therapy can be included in the study when there is no obvious sign of recurrence.
Patients need to receive systemic cortisol treatment (>10mg prednisolone [or equivalent dose] / day) or use other immunosuppressive drugs within 14 days after enrollment. Note: inhaled or topical corticosteroids, or adrenal hormone replacement therapy (>10mg prednisolone [or equivalent dose] / day) can be accepted for patients without obvious autoimmune disease.
Patients with grade 3-4 interstitial lung disease.
Single group
Ivonescimab Combined With Chemotherapy
DrugIvonescimab 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.
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.
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).
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).
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.
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Sun Yat-sen University
Lead sponsor
Sun Yat-Sen University Cancer Center
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
