Surufatinib as Neoadjuvant Treatment for Locally Advanced or Metastatic Differentiated Thyroid Cancer

Surufatinib as Neoadjuvant Treatment for Locally Advanced or Metastatic Differentiated Thyroid Cancer: an Open-label, Multicenter, Single-arm Study

Surufatinib as Neoadjuvant Treatment for Locally Advanced or Metastatic Differentiated Thyroid Cancer (NCT05989425) is a Phase 2 interventional studying Differentiated Thyroid Cancer, sponsored by Fudan University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Locally advanced thyroid cancer has a wide range of surgery, large trauma and high local recurrence rate. It is one of the main causes of death in patients with thyroid cancer. Therefore, more effective treatments are urgently needed. This study is designed to evaluate the efficacy and safety of the Surufatinib for Locally Advanced Thyroid Cancer.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Differentiated Thyroid Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 32 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Locally advanced or metastatic thyroid cancer confirmed by histology or cytology, including papillary thyroid carcinoma, follicular thyroid carcinoma, poorly differentiated thyroid cancer, particularly differentiated thyroid cancer. Locally advanced stage refers to: 1) Primary tumor with invasion or adhesion of organs and structures, such as recurrent laryngeal nerve, esophagus, trachea, larynx, encirclement of neck large vessels, mediastinal vessels, extensive invasion of skin, subcutaneous soft tissue or neck muscles; 2). AJCC T4 Stage; 3). Difficult to achieve R0/R1 resection during preoperative assessment; - Age 14-75 years; - At least one measurable lesion (RECIST 1.1); - Eastern Cooperative Oncology Group (ECOG) score 0-1; - Expected survival time ≥ 12 weeks; - The main organ functions meet the following criteria: Absolute neutrophil value (ANC) ≥ 1.5 × 109 / L; Platelet (PLT) ≥80 × 109 / L; Hemoglobin (HB) ≥9g / dL; White blood cell count\> 1.5 × 109 / L; Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN, if with liver metastases, ALT and AST ≤ 5 ULN; Serum creatinine (Cr) ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 50ml / min; - Subjects of potential fertility are required to use at least one medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment and for 180 days after the end of the study treatment; The serum HCG test must be negative before the first medication. Who Should NOT Join This Trial: - Prior treatment with anti-angiogenic small molecule targeted drugs; - Received other anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, etc.) within 4 weeks prior to treatment, except for TSH suppression treatment; - Allergy to the study drug ; - Have a history of serious cardiovascular and cerebrovascular diseases; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Locally advanced or metastatic thyroid cancer confirmed by histology or cytology, including papillary thyroid carcinoma, follicular thyroid carcinoma, poorly differentiated thyroid cancer, particularly differentiated thyroid cancer. Locally advanced stage refers to: 1) Primary tumor with invasion or adhesion of organs and structures, such as recurrent laryngeal nerve, esophagus, trachea, larynx, encirclement of neck large vessels, mediastinal vessels, extensive invasion of skin, subcutaneous soft tissue or neck muscles; 2). AJCC T4 Stage; 3). Difficult to achieve R0/R1 resection during preoperative assessment; * Age 14-75 years; * At least one measurable lesion (RECIST 1.1); * Eastern Cooperative Oncology Group (ECOG) score 0-1; * Expected survival time ≥ 12 weeks; * The main organ functions meet the following criteria: Absolute neutrophil value (ANC) ≥ 1.5 × 109 / L; Platelet (PLT) ≥80 × 109 / L; Hemoglobin (HB) ≥9g / dL; White blood cell count\> 1.5 × 109 / L; Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN, if with liver metastases, ALT and AST ≤ 5 ULN; Serum creatinine (Cr) ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 50ml / min; * Subjects of potential fertility are required to use at least one medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment and for 180 days after the end of the study treatment; The serum HCG test must be negative before the first medication. Exclusion Criteria: * Prior treatment with anti-angiogenic small molecule targeted drugs; * Received other anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, etc.) within 4 weeks prior to treatment, except for TSH suppression treatment; * Allergy to the study drug ; * Have a history of serious cardiovascular and cerebrovascular diseases; * Patients whose imaging showed that the tumor had invaded the important blood vessels or the researchers judged that the tumor was likely to invade important blood vessels during the subsequent study period and caused fatal bleeding; * Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg); * The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); * The investigator considered that the subject was not suitable to participate in the study due to any clinical or laboratory abnormalities or other reasons.

Treatments Being Tested

DRUG

surufatinib

Surufatinib is a tablet in the form of 50mg, oral, once a day.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05989425), the sponsor (Fudan University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05989425 clinical trial studying?

Who can participate in NCT05989425?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05989425?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05989425. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05989425. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.