undifferentiated carcinoma of thyroid gland
Conditions
Interventions
Group 1:Carrilizumab dose: (200mg, q3w)
Apatinib dose: (250mg, qd)
Capecitabine dose: (1000mg/m^2,bid,D1-D14) (every 21 days)
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Any gender, age from 18 to 75 years old; 2) Patients with pathologically proven untreated undifferentiated thyroid cancer; 3) Patients with locally advanced or metastatic thyroid undifferentiated carcinoma who are inoperable by MDT; 4) Patients without economic conditions to detect Braf V600E or detect mutations without economic conditions to treat trametinib combined with dalafenib; 5)Before treatment, there is at least one measurable lesion on CT or MRIBefore treatment, there is at least one measurable lesion on CT or MRI 6) ECOG 0-2; 7) Specimens can be provided for PD-L1 detection with CPS score >= 1 (DAKO22C3); 8) Survival expectancy is expected to be no less than 3 months; 9) 1 week before treatment, the laboratory test standards were met: absolute neutrophil count >= 1.5x10^12/L; Platelet >= 100x10^9/L; Hemoglobin >= 90g/L; International standardized ratio or prothrombin time = 60mL/min/1.73m^2; Serum total bilirubin <= 1.5X ULN(Gilbert syndrome patients with total bilirubin < 3X ULN can be enrolled); 10) Can understand this study and have signed the informed consent; 11) Patients with follow-up conditions.
Exclusion criteria
Exclusion criteria: (1) Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as antibodies targeting ICOS, CD40, CD137, GITR, and Ox40 targets), immune cell therapy, etc. Any treatment that targets the immune mechanisms of the tumor; (2) previous treatment with small molecule inhibitors or antibodies targeting VEGFR targets; (3) Patients with active autoimmune disease or a history of autoimmune disease that may recur; Note: Patients with the following diseases are not excluded and may enter further screening: a. controlled type 1 diabetes mellitus; b. Hypothyroidism (if controlled with hormone replacement therapy alone); c. controlled celiac disease; d. Skin diseases that do not require systemic treatment (e.g. Vitiligo, psoriasis, alopecia); e. any other disease that is not expected to recur in the absence of an external trigger; (4) any active malignancy within grade 1 potassium, sodium, or corrected calcium levels despite standard drug therapy or >= grade 3 hypoalbuminemia; (7) Have a history of the following diseases: interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, hypertension, etc.; (8) severe chronic or active infections (including tuberculosis infections) requiring systemic antibiotic, antimicrobial, or antiviral treatment occurred prior to enrollment or within 14 days prior to the first administration of the investigational drug; (9) Known history of HIV infection; (10) Patients with untreated chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA>= 500 IU/mL or active hepatitis C virus (HCV) carriers should be excluded. Remarks: Non-active hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA = grade 2 ventricular arrhythmias occurred within <= 6 months prior to enrollment or first administration of the study drug 6) A history of cerebrovascular accident within 6 months prior to enrollment or the first administration of the study drug (14) A history of severe hypersensitivity to other monoclonal a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression-free survival;Overall survival;Duration of remission;adverse effect;serious adverse effect;living quality; | — |
Countries
China
Contacts
Public ContactZhang Shichuan
Sichuan Cancer Hospital
Outcome results
None listed