Actively Recruiting
Donafenib Combined With PD-1 Antibody Sintilimab for Pre-Surgery Treatment in Locally Advanced Thyroid Cancer A Phase II Study Evaluating Effectiveness and Safety
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
Researchers are evaluating the effectiveness and safety of a combined treatment using Donafenib and the PD-1 antibody Sintilimab as neoadjuvant therapy for patients with locally advanced differentiated thyroid carcinoma. This phase II study focuses on patients whose tumors are difficult to remove completely by surgery alone, aiming to assess how well this drug combination works before surgery and its safety profile. The study includes patients aged 18 to 80 years with measurable tumor lesions and good overall health status. Participants receive Donafenib together with Sintilimab as the initial treatment to shrink or control the tumor. Those who respond to this neoadjuvant therapy and become eligible for surgery will then undergo surgical tumor removal. The treatment period includes administration of these drugs followed by surgery if possible. The study monitors patients closely during this treatment phase. During the study, participants undergo tumor biopsies or surgery at enrollment and exit, along with regular imaging scans to measure tumor response according to established criteria. Researchers assess the objective response rate from enrollment until the end of treatment at four weeks. Safety evaluations, physical condition scores, and laboratory tests are performed to monitor organ function and detect any side effects. The total participation duration includes treatment, surgery, and follow-up assessments to evaluate treatment outcomes and patient safety.
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
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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
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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