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

Primary Purpose

Differentiated Thyroid Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
surufatinib
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Differentiated Thyroid Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

surufatinib

Arm Description

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.

Outcomes

Primary Outcome Measures

ORR
Objective Response Rate

Secondary Outcome Measures

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
DCR
Disease Control Rate
PFS
Progression Free Survival
AE
Adverse Events

Full Information

First Posted
August 3, 2023
Last Updated
August 9, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05989425
Brief Title
Surufatinib as Neoadjuvant Treatment for Locally Advanced or Metastatic Differentiated Thyroid Cancer
Official Title
Surufatinib as Neoadjuvant Treatment for Locally Advanced or Metastatic Differentiated Thyroid Cancer: an Open-label, Multicenter, Single-arm Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2023 (Anticipated)
Primary Completion Date
August 4, 2026 (Anticipated)
Study Completion Date
August 4, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Differentiated Thyroid Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surufatinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
surufatinib
Intervention Description
Surufatinib is a tablet in the form of 50mg, oral, once a day.
Primary Outcome Measure Information:
Title
ORR
Description
Objective Response Rate
Time Frame
approximately 1 years
Secondary Outcome Measure Information:
Title
R0/1 resection rate
Description
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
Title
DCR
Description
Disease Control Rate
Time Frame
approximately 1 years
Title
PFS
Description
Progression Free Survival
Time Frame
approximately 1 years
Title
AE
Description
Adverse Events
Time Frame
From first dose to within 30 days after the last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiaying Chen
Phone
86-18017317883
Email
chen_lain@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang
Email
headneck@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiaying Chen
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yu Wang
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaying Chen
Phone
86-18017317883
Email
chen_lain@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yu Wang
Email
headneck@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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