anaplastic thyroid cancer
Conditions
Interventions
single arm: sintilimab combined with anlotinib
Sponsors
Cancer Hospital Chinese Academy of Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Voluntarily signed the informed consent; 2) Age = 18 years; 3) Histologically diagnosed anaplastic thyroid cancer patients, inoperable IVB stage or IVC stage; 4) Acceptable neoadjuvant or adjuvant or systemic therapy, and the number of previous treatment lines is not limited; 5) According to the RECIST 1.1 criteria, the subject has at least one measurable target lesion confirmed by imaging examination during the screening period ( Lesions with a longest diameter = 10 mm, or lymph nodes with a short diameter = 15 mm), measurable lesions should not have received local treatment such as radiotherapy (lesions located in the area of previous radiotherapy, if confirmed to have progressed, can also be selected as target lesions); 6) During the screening period of subjects, tumor tissue samples must be provided for PD-L1 expression level detection; 7) Patients with Eastern Cooperative Oncology Group (ECOG) score performance status of 0 or 1; 8) The expected survival period is at least 3 months; 9) Appropriate organ and hematopoietic function, according to the following laboratory tests: Neutrophil count (NEUT#) = 1.5 G/L; White blood cell count (WBC) = 3.0 G/L; Platelet count = 100 G/L; Hemoglobin=90 g/L; Serum creatinine=1.5 x the upper limit of normal (ULN); AST and ALT=3 x ULN; Serum total bilirubin (TBIL)=1.5 x ULN; International normalized ratio (INR) = 2 x ULN, or activated partial thromboplastin time (APTT) = 1.5 x ULN (except for patients receiving anticoagulant therapy); 10) Women of childbearing age, must be performed within 7 days before the first dose Blood pregnancy test was negative. 11) Agree to use medically approved effective contraceptive measures (such as intrauterine devices, contraceptives or condoms during the study treatment period and at least 6 months after the last treatment) );
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) Patients who are suitable for local treatment; 2) Differentiated thyroid cancer or medullary thyroid cancer. Patients who have progressed from differentiated thyroid cancer to anaplastic thyroid cancer can be enrolled if their measurable lesions conform to the clinical characteristics of anaplastic thyroid cancer (such as rapid progression and/or positive FDG-PET results, etc.); 3) Before the first use of the study drug Patients diagnosed with any other malignancy within 3 years, excluding malignancies with low risk of metastasis and mortality (5-year survival >90%), such as adequately treated basal cell or squamous cell skin cancer or cervical in situ Carcinoma and other carcinomas in situ are excluded; 4) Received anti-tumor monoclonal antibody therapy within 4 weeks before the first dose, or the adverse events caused by the drugs received before 4 weeks have not recovered (ie = grade 1 or reach the baseline level ); 5) Received chemotherapy, or radiotherapy, or small molecule targeted therapy within 2 weeks before the first dose, or the adverse events caused by the previously received drugs have not recovered (ie, = grade 1 or reached the baseline level). Note: Subjects with = grade 2 neuropathy or = grade 2 alopecia are excluded; 6) Any factors that affect the patient's oral medication, such as inability to swallow, post gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.; 7) After the investigator judges that there is a risk of major bleeding; 8) Patients who have received anti-PD-1 or other immune checkpoint inhibitor therapy such as PD-L1 and CTLA-4; ) patients with metastatic and/or cancerous meningitis; 10) with active autoimmune disease (except psoriasis) and requiring systemic therapy (ie, corticosteroids or immunosuppressive drugs) in the past 2 years. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is excluded; 11) Patients who are expected to have major surgery within 28 days before the first dose or during this study. (excluding diagnostic surgery). Definition of major surgery: At least 3 weeks of recovery time is required after surgery to be able to accept the surgery treated in this study; 12) Systemic corticosteroids (dose equivalent to >10mg prednisone/day) are required within 14 days before enrollment or during the study period ) or other immunosuppressive drugs; the following conditions are allowed to enroll: Allow subjects to use topical or inhaled glucocorticoids; 13) Allow short-term (=7 days) use of glucocorticoids for prevention or treatment of non- Autoimmune allergic diseases; 14) Existing interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, etc.; 15) Subjects with uncontrolled cardiovascular diseases, including but not limited to: Such as (1) NYHA class II or above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia without clinical intervention or still after clinical intervention Poor control; (5) In the resting state, the average corrected QT interval (QTc) obtained by the electrocardiogram (ECG) examination is >470 msec (for the first abnormality, repeat the test once within 48 hours, with 2 averaged results). Various clinically significant abnormalities of cardiac rhythm, conduction, and resting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate (ORR);disease control rate (DCR);progression-free survival;overall survival (OS);adverse events; | — |
Countries
China
Contacts
Public ContactGuilin
Cance Hospital Chinese Academy of Medical Science
Outcome results
None listed