Actively Recruiting
Donafenib Combined With Anti-PD-1 Antibody for Neoadjuvant Therapy in Locally Advanced Thyroid Cancer
Led by Yu Wang · Updated on 2025-01-22
14
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Donafenib Combined With Anti-PD-1 Antibody for Neoadjuvant Therapy in Locally Advanced Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily enroll and sign a written informed consent form
- Age between 18 and 80 years, any gender
- Diagnosed with locally advanced differentiated thyroid carcinoma by pathology
- Tumor is difficult to fully remove by surgery or meets AJCC T4 stage criteria
- Willing to have tumor biopsy or surgery at enrollment and study end
- No prior anti-tumor treatment
- At least one measurable tumor lesion by imaging
- Eastern Cancer Collaborative Group (ECOG) performance status score of 0 to 2
- Expected survival time greater than 3 months
- Female patients who can have children must have a negative pregnancy test within 7 days before treatment
- Patients able to use reliable contraception during treatment and 60 days after last dose
- Normal major organ function based on blood, liver, kidney, coagulation tests, and myocardial enzymes
You will not qualify if you...
- Other types of thyroid cancer not related to differentiated thyroid carcinoma
- Having repeat radical surgery for thyroid cancer
- Symptomatic central nervous system metastasis or cancerous meningitis
- History of other primary cancers within 5 years except certain treated skin and bladder tumors
- Congenital or acquired immunodeficiency
- Active or past autoimmune or inflammatory diseases except resolved childhood vitiligo or asthma
- History of severe mental illness
- Diseases affecting drug absorption or metabolism
- Major surgery within 4 weeks before study or expected during study
- Recent iodine-131 ablation or local anti-tumor treatments within 3 months
- Previous organ or bone marrow transplant
- Prior treatment with VEGF-targeting drugs or immune checkpoint inhibitors
- Recent systemic immunosuppressive treatment except low-dose corticosteroids or local use
- Use of drugs that prolong QTc interval or affect drug metabolism
- Allergies to study drugs or their components
- Tumor invasion of major blood vessels or high risk of fatal bleeding
- Active bleeding or coagulation disorders
- Recent gastrointestinal bleeding or risk factors for bleeding
- Recent gastrointestinal perforation or abscess
- Recent thrombosis or thromboembolism
- Significant cardiovascular diseases
- Active infections including HIV, hepatitis B or C, tuberculosis
- Other significant clinical or lab abnormalities affecting safety
- Unhealed surgery wounds or serious postoperative complications
- Recent live vaccine use
- Pregnant or breastfeeding, or unwilling to use contraception
- Recent substance abuse
- Participation in other drug or device trials within 4 weeks
- Unable to follow study protocol or attend follow-up
- Any other condition deemed unsuitable by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
Y
Yu Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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