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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.

Phase 2RecruitingYu WangNCT06787911Data as of May 2026

Treatment: Donafeib with SintilimabThis 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.

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Extracted eligibility criteria

Cancer type

Thyroid Cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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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