Anaplastic Thyroid Cancer
Conditions
Interventions
Intervention group:Anlotinib plus benmelstobart treatment
BRAF positive and receiving dabrafenib and trametinib treatment as recommended by ATA guidelines:None
Sponsors
The First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age older than 18 years; 2.With pathologically confirmed anaplastic thyroid carcinoma; 3. With measurable lesions (according to RECIST 1.1 criteria); 4. Clinically evaluated as unresectable; 5. ECOG PS score = 1.5 × 10^9/L; Platelet count >= 100 × 10^9/L; Liver and kidney functions: Serum creatinine (SCr) = 50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN); Aspartate transaminase (AST) or alanine transaminase (ALT) level <= 2.5 times the upper limit of normal (ULN); 7. Normal coagulation function, without active bleeding and thrombotic diseases; International normalized ratio (INR) <= 1.5 × ULN; Activated partial thromboplastin time (APTT) <= 1.5 × ULN; Prothrombin time (PT) <= 1.5 × ULN; For patients receiving therapeutic anticoagulant therapy: a stable anticoagulant treatment plan is required, and INR has been stable within 28 days before the start of the study treatment. 8. Subjects voluntarily participate in this study, have good compliance, and cooperate with safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Subjects with concurrent or a history of other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 2. Known history of allergy to macromolecular protein preparations or known ingredients of the applied drugs; 3. Previous receipt of systemic anti-VEGFR drugs or anti-PD-1, anti-PD-L1 drug therapy; 4. Uncontrolled hypertension despite optimal treatment; 5. Having poorly controlled clinical cardiac symptoms or diseases; 6. Subjects with any active autoimmune disease or a history of autoimmune disease; 7. Subjects who are using immunosuppressants, or systemic or absorbable local hormone therapy for immunosuppressive purposes (prednisone dose > 10mg/day or other hormones with equivalent efficacy) and continue to use them within 2 weeks before enrollment; 8. Concomitant central nervous system metastasis; 9. Subjects with active infection or unexplained fever > 38.5 degrees during screening or before the first dose (subjects with fever caused by tumors can be enrolled as judged by the researcher); 10. Subjects with congenital or acquired immune deficiency, such as HIV ,or active hepatitis (transaminases do not meet the inclusion criteria; for hepatitis B: HBV DNA >=1000 IU/ml; for hepatitis C: HCV RNA >= 1000 IU/ml); 11. Receipt of live vaccines within 4 weeks before study drug administration or likely to be vaccinated during the study period; 12. Subjects with known history of psychotropic drug abuse, alcoholism or drug addiction; 13. Pregnant or lactating women or subjects planning to have children during the trial period; 14. Those deemed by the researcher to be excluded from the study, for example, subjects with other factors that may lead to the forced termination of the study as judged by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Objective Response Rate;Resection rate;Patient Reported Outcomes; | — |
Countries
China
Contacts
Public ContactHaipeng Xiao
The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed