Camrelizumab and Apatinib for Neoadjuvant Therapy in Thyroid Cancer

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

Official Title
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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

Conditions
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Thyroid Cancer

Intervention / Treatment
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* Drug: Camrelizumab and Apatinib
* Procedure: surgery
* Procedure: core needle biopsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant Camrelizumab + Apatinib<br>Apatinib 250mg, po qd, and Camrelizumab 200mg, iv q2w as neoadjuvant treatment. 28 days as one cycle, for at least two cycles. | Drug: Camrelizumab and Apatinib<br>* All patients will receive Camrelizumab and Apatinib for at least two cycles of neoadjuvant treatment<br>Procedure: surgery<br>* Perform surgery if operable after neoadjuvant therapy<br>Procedure: core needle biopsy<br>* Perform core needle biopsy if inoperable after neoadjuvant therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | ORR | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0/1 resection rate | R0/1 resection rate if operable | at the time of surgery | 
| Disease control rate | DCR | at the time point of 6 weeks | 
| Overall survival | OS | up to 3 years | 
| Adverse Events | AEs | from the first drug administration to within 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid cancer, locally advanced, neoadjuvant, Camrelizumab, Apatinib