To hear about similar clinical trials, please enter your email below
Trial Title:
Surufatinib as Neoadjuvant Treatment for Locally Advanced or Metastatic Differentiated Thyroid Cancer
NCT ID:
NCT05989425
Condition:
Differentiated Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
surufatinib
Description:
Surufatinib is a tablet in the form of 50mg, oral, once a day.
Arm group label:
surufatinib
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiaying Chen
Phone:
86-18017317883
Email:
chen_lain@hotmail.com
Contact backup:
Last name:
Yu Wang
Email:
headneck@126.com
Start date:
August 4, 2023
Completion date:
August 4, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05989425
