Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05989425

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

Led by Fudan University · Updated on 2023-08-14

32

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Locally advanced or metastatic thyroid cancer confirmed by histology or cytology, including papillary, follicular, poorly differentiated, or differentiated thyroid cancer
  • Locally advanced stage with tumor invasion or adhesion to specific organs or structures, AJCC T4 stage, or difficult to achieve R0/R1 resection
  • Age between 14 and 75 years
  • At least one measurable lesion according to RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Expected survival time of at least 12 weeks
  • Adequate organ function including specific blood counts and liver and kidney function within defined limits
  • For subjects of potential fertility, use of approved contraception during treatment and for 180 days after, with negative serum HCG test before first medication
Not Eligible

You will not qualify if you...

  • Prior treatment with anti-angiogenic small molecule targeted drugs
  • Received other anti-tumor therapy (including chemotherapy, radiotherapy) within 4 weeks before treatment, except TSH suppression
  • Allergy to Surufatinib
  • History of serious cardiovascular or cerebrovascular diseases
  • Tumor invasion of important blood vessels or high risk of fatal bleeding as judged by imaging or researchers
  • Uncontrolled hypertension with systolic 65150 mmHg or diastolic 65100 mmHg
  • Other malignant tumors within past 5 years except cured basal cell carcinoma of skin or carcinoma in situ of cervix
  • Investigator judgement deeming subject unsuitable for study due to clinical or laboratory abnormalities or other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

J

Jiaying Chen

CONTACT

Y

Yu Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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