Camrelizumab and Apatinib for Neoadjuvant Therapy in Thyroid Cancer

Phase 2

• Conditions: Thyroid Cancer
• Interventions: Drug: Camrelizumab and Apatinib; Procedure: surgery; Procedure: core needle biopsy

• Registration Number: NCT04612894
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2020-11-02
• Last Update Submitted: 2020-11-02
• Study First Posted: 2020-11-03
• Last Update Posted: 2020-11-03
• Study Start: 2020-12-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant Camrelizumab + Apatinib	Camrelizumab and Apatinib	Apatinib 250mg, po qd, and Camrelizumab 200mg, iv q2w as neoadjuvant treatment. 28 days as one cycle, for at least two cycles.
Neoadjuvant Camrelizumab + Apatinib	surgery	Apatinib 250mg, po qd, and Camrelizumab 200mg, iv q2w as neoadjuvant treatment. 28 days as one cycle, for at least two cycles.
Neoadjuvant Camrelizumab + Apatinib	core needle biopsy	Apatinib 250mg, po qd, and Camrelizumab 200mg, iv q2w as neoadjuvant treatment. 28 days as one cycle, for at least two cycles.

Primary Outcome Measures

Name	Time	Method
Objective response rate	up to 24 weeks	ORR

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China