Using Surufatinib to Treat Advanced Thyroid Cancer Before Surgery

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

This study tests if the drug Surufatinib can help people with advanced thyroid cancer do better before surgery and lower the chances of cancer coming back.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, Surufatinib
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05989425 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Surufatinib as a neoadjuvant treatment for patients with locally advanced or metastatic differentiated thyroid cancer. The study aims to improve surgical outcomes and reduce recurrence rates by administering Surufatinib prior to surgery. Participants will be closely monitored for their response to the treatment and any potential side effects. The trial focuses on patients with specific types of thyroid cancer that are difficult to treat surgically.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 14-75 with locally advanced or metastatic differentiated thyroid cancer that is difficult to resect surgically.

Not a fit: Patients with early-stage thyroid cancer or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to better surgical outcomes and improved survival rates for patients with advanced thyroid cancer.

How similar studies have performed: While there is ongoing research in this area, the use of Surufatinib as a neoadjuvant treatment for this specific condition is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jiaying Chen — Fudan University
• Study coordinator: Jiaying Chen

Conditions Differentiated Thyroid Cancer