Camrelizumab and Apatinib for Neoadjuvant Therapy in Thyroid Cancer

Thyroid Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04612894
• Other study ID #: CALA-TC
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2020
• Source: Fudan University
• Contact: Yu Wang, M.D.
• Phone: 86-021-64175590
• Email: neck130[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 31
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Camrelizumab and Apatinib
All patients will receive Camrelizumab and Apatinib for at least two cycles of neoadjuvant treatment

Procedure:
• surgery
Perform surgery if operable after neoadjuvant therapy
• core needle biopsy
Perform core needle biopsy if inoperable after neoadjuvant therapy

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	ORR	up to 24 weeks
Secondary	R0/1 resection rate	R0/1 resection rate if operable	at the time of surgery
Secondary	Disease control rate	DCR	at the time point of 6 weeks
Secondary	Overall survival	OS	up to 3 years
Secondary	Adverse Events	AEs	from the first drug administration to within 90 days after surgery