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.
Sun Yat-sen University
Lead sponsor
Sun Yat-Sen University Cancer Center
Sponsor institution