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Camrelizumab and Apatinib for Neoadjuvant Therapy in Thyroid Cancer

Primary Purpose

Thyroid Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab and Apatinib
surgery
core needle biopsy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring thyroid cancer, locally advanced, neoadjuvant, Camrelizumab, Apatinib

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient volunteered to participate in the study and signed an informed consent form;
  • Pathologically diagnosed locally advanced thyroid cancer, including papillary thyroid cancer, medullary cancer, follicular cancer, poorly differentiated cancer, etc., require surgical resection with or without distant metastasis;
  • Preoperative assessment of locally advanced thyroid cancer (unable to achieve R0/1 resection or T4 disease);
  • Have at least one measurable lesion (RECIST 1.1);
  • Age>=14 years, Eastern Cooperative Oncology Group (ECOG) score 0-1;
  • Patient agree to receive surgery/ core needle biopsy before and after neoadjuvant treatment.
  • The main organ functions meet the criteria before treatment.

Exclusion Criteria:

  • Patients who have previously been treated with immune checkpoint inhibitors (including but not limited to nivolizumab, pembrolizumab, teriplizumab, sintilizumab, etc.);
  • Received external radiation therapy or iodine-131 therapy within the past 28 days; or planned systemic anti-tumor therapy during this study;
  • Pathologically confirmed non-thyroid epithelial cell-derived malignant tumors (including lymphoma, metastatic cancer, sarcoma, etc.);
  • With other uncontrolled / under treatment malignancies;
  • Those who have multiple factors (such as inability to swallow) that affect oral medication;
  • Patients with any severe and / or uncontrolled illness,
  • 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;
  • According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of patients or affect patients to complete the research.

Sites / Locations

  • Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant Camrelizumab + Apatinib

Arm Description

Apatinib 250mg, po qd, and Camrelizumab 200mg, iv q2w as neoadjuvant treatment. 28 days as one cycle, for at least two cycles.

Outcomes

Primary Outcome Measures

Objective response rate
ORR

Secondary Outcome Measures

R0/1 resection rate
R0/1 resection rate if operable
Disease control rate
DCR
Overall survival
OS
Adverse Events
AEs

Full Information

First Posted
October 30, 2020
Last Updated
November 2, 2020
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04612894
Brief Title
Camrelizumab and Apatinib for Neoadjuvant Therapy in Thyroid Cancer
Official Title
The Efficacy and Safety of Anti-PD-1 Antibody Camrelizumab Combined With Apatinib for Neoadjuvant Therapy in Locally Advanced Thyroid Cancer: a Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the efficacy and safety of anti-PD-1 antibody Camrelizumab combined with Apatinib for neoadjuvant therapy in locally advanced thyroid cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
thyroid cancer, locally advanced, neoadjuvant, Camrelizumab, Apatinib

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant Camrelizumab + Apatinib
Arm Type
Experimental
Arm Description
Apatinib 250mg, po qd, and Camrelizumab 200mg, iv q2w as neoadjuvant treatment. 28 days as one cycle, for at least two cycles.
Intervention Type
Drug
Intervention Name(s)
Camrelizumab and Apatinib
Intervention Description
All patients will receive Camrelizumab and Apatinib for at least two cycles of neoadjuvant treatment
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
Perform surgery if operable after neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
core needle biopsy
Intervention Description
Perform core needle biopsy if inoperable after neoadjuvant therapy
Primary Outcome Measure Information:
Title
Objective response rate
Description
ORR
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
R0/1 resection rate
Description
R0/1 resection rate if operable
Time Frame
at the time of surgery
Title
Disease control rate
Description
DCR
Time Frame
at the time point of 6 weeks
Title
Overall survival
Description
OS
Time Frame
up to 3 years
Title
Adverse Events
Description
AEs
Time Frame
from the first drug administration to within 90 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient volunteered to participate in the study and signed an informed consent form; Pathologically diagnosed locally advanced thyroid cancer, including papillary thyroid cancer, medullary cancer, follicular cancer, poorly differentiated cancer, etc., require surgical resection with or without distant metastasis; Preoperative assessment of locally advanced thyroid cancer (unable to achieve R0/1 resection or T4 disease); Have at least one measurable lesion (RECIST 1.1); Age>=14 years, Eastern Cooperative Oncology Group (ECOG) score 0-1; Patient agree to receive surgery/ core needle biopsy before and after neoadjuvant treatment. The main organ functions meet the criteria before treatment. Exclusion Criteria: Patients who have previously been treated with immune checkpoint inhibitors (including but not limited to nivolizumab, pembrolizumab, teriplizumab, sintilizumab, etc.); Received external radiation therapy or iodine-131 therapy within the past 28 days; or planned systemic anti-tumor therapy during this study; Pathologically confirmed non-thyroid epithelial cell-derived malignant tumors (including lymphoma, metastatic cancer, sarcoma, etc.); With other uncontrolled / under treatment malignancies; Those who have multiple factors (such as inability to swallow) that affect oral medication; Patients with any severe and / or uncontrolled illness, 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; According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of patients or affect patients to complete the research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang, M.D.
Phone
86-021-64175590
Ext
65805
Email
neck130@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nai-si Huang, M.D.
Phone
86-021-64175590
Ext
67816
Email
huangnaisi@fudan.edu.cn
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Wang, M.D.
Phone
86-021-64175590
Ext
65805
Email
neck130@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Camrelizumab and Apatinib for Neoadjuvant Therapy in Thyroid Cancer

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