OncoMatch/Clinical Trials/NCT06787911
Donafenib Combined With Anti-PD-1 Antibody for Neoadjuvant Therapy in Locally Advanced Thyroid Cancer
Is NCT06787911 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Donafeib with Sintilimab for thyroid cancer.
Treatment: Donafeib with Sintilimab — This study is a single-arm intervention study. Locally advanced differentiated thyroid carcinoma patients receive neoadjuvant therapy with Donafenib and PD-1 antibody Sintilimab and those who can undergo surgery after neoadjuvant therapy receive surgical treatment. The aim of the study is to evaluate the efficacy and safety of Donafenib combined with PD-1 antibody in neoadjuvant therapy of locally advanced thyroid cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Thyroid Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: iodine-131 ablation
Have received iodine-131 ablation or other local anti-tumor treatments within the past 3 months
Cannot have received: targeted therapy drugs targeting VEGF (anlotinib, apatinib, bevacizumab)
Previously received targeted therapy drugs targeting VEGF, including but not limited to anlotinib, apatinib, bevacizumab, etc
Cannot have received: immune therapy drugs (anti CTLA-4, anti PD-1, anti PD-L1, anti PD-L2, anti CD137)
Exception: Therapeutic anti-tumor vaccines are not included
Previously received immune therapy drugs including but not limited to anti CTLA-4, anti PD-1, anti PD-L1, anti PD-L2, anti CD137. Therapeutic anti-tumor vaccines are not included
Cannot have received: cytotoxic therapy (mitomycin C)
including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or have used mitomycin C within 6 weeks before receiving the investigational drug treatment)
Cannot have received: organ or allogenic bone marrow transplantation
Previously received organ or allogenic bone marrow transplantation
Lab requirements
Blood counts
Hemoglobin>=90 g/L; ANC>=1.5 × 10^9/L; Platelet count>=80 × 10^9/L
Kidney function
Creatinine<=1.5 x ULN; Urinary protein<2+ (if urinary protein>=2+, 24-hour urine protein quantification<1.0g can be included)
Liver function
Total bilirubin<=1.5 x ULN; AST and ALT<=2.5 x ULN (ALT or AST<=5 x ULN allowed for subjects with liver metastasis)
Cardiac function
Myocardial enzyme profiles within normal range (simple laboratory abnormalities not clinically significant were also allowed to be included)
Normal function of major organs, i.e. meeting the following criteria: Blood routine examination...Blood biochemistry test...Coagulation function...Others...Myocardial enzyme profiles were within the normal range
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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