Thyroid Cancer
Conditions
Keywords
thyroid cancer, locally advanced, neoadjuvant, Camrelizumab, Apatinib
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.
Interventions
All patients will receive Camrelizumab and Apatinib for at least two cycles of neoadjuvant treatment
PROCEDUREsurgery
Perform surgery if operable after neoadjuvant therapy
PROCEDUREcore needle biopsy
Perform core needle biopsy if inoperable after neoadjuvant therapy
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | up to 24 weeks | ORR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0/1 resection rate | at the time of surgery | R0/1 resection rate if operable |
| Disease control rate | at the time point of 6 weeks | DCR |
| Overall survival | up to 3 years | OS |
| Adverse Events | from the first drug administration to within 90 days after surgery | AEs |
Countries
China
Contacts
Primary ContactYu Wang, M.D.
Backup ContactNai-si Huang, M.D.
Outcome results
None listed