Camrelizumab and Apatinib for Neoadjuvant Therapy in Thyroid Cancer

Fudan University

Status and phase

Unknown

Phase 2

Conditions

Thyroid Cancer

Treatments

Drug: Camrelizumab and Apatinib

Procedure: surgery

Procedure: core needle biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT04612894

CALA-TC

Details and patient eligibility

About

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

Enrollment

31 estimated patients

Sex

All

Ages

14+ years old

Volunteers

No 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.