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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • surufatinib

    Drug

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

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: surufatinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Objective Response Rate

Time frame
approximately 1 years

Secondary outcomes

1

R0/1 resection rate

R0 and R1 resection rate reviewed by operation team and pathologists R0 and R1 resection rate reviewed by operation team and pathologists R0 and R1 resection rate reviewed by operation team and pathologists dR0 and R1 resection rate reviewed by operation team and pathologists R0 and R1 resection rate reviewed by operation team and pathologists R0 and R1 resection rate reviewed by operation team and pathologists dvxddR0 and R1 resection rate reviewed by operation team and pathologists

Time frame
approximately 1 years
2

DCR

Disease Control Rate

Time frame
approximately 1 years
3

PFS

Progression Free Survival

Time frame
approximately 1 years
4

AE

Adverse Events

Time frame
From first dose to within 30 days after the last dose

Other outcomes

Sponsors and contacts

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