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

NCT05989425 | Recruiting Phase 2

• 1 other identifier: HMPL-012-SPRING-T102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Differentiated Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  approximately 1 years

Secondary Outcomes (4)

• R0/1 resection rate

  approximately 1 years

• DCR

  approximately 1 years

• PFS

  approximately 1 years

• AE

  From first dose to within 30 days after the last dose

Study Arms (1)

surufatinib

EXPERIMENTAL

Surufatinib 300mg will be taken orally once daily continuously through a 28-day cycle of study treatment. After treatment, the patients will receive operation treatment if the tumor is evaluated as resectable cases by clinical examination. Patients with high risk of postoperative recurrence will receive 131I treatment. After 131I treatment, maintenance treatment with surufatinib will be determined according to the recurrence risk stratification.

Drug: surufatinib

Interventions

surufatinib DRUG

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

surufatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

surufatinib

Study Officials

• Jiaying Chen

  Fudan University

  PRINCIPAL INVESTIGATOR

• Yu Wang

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaying Chen

CONTACT

86-18017317883; chen_lain@hotmail.com

Yu Wang

CONTACT

headneck@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Fudan University Shanghai Cancer

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 4, 2023
• Primary Completion (Estimated): August 4, 2026
• Study Completion (Estimated): August 4, 2026
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)