Camrelizumab and Apatinib for Neoadjuvant Therapy in Thyroid Cancer

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Thyroid Cancer
• Intervention / Treatment: Drug: Camrelizumab and Apatinib; Procedure: surgery; Procedure: core needle biopsy

• Study Type: Interventional
• Enrollment (Anticipated): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Neoadjuvant Camrelizumab + Apatinib; 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; All patients will receive Camrelizumab and Apatinib for at least two cycles of neoadjuvant treatment; Procedure: surgery; Perform surgery if operable after neoadjuvant therapy; Procedure: core needle biopsy; Perform core needle biopsy if inoperable after neoadjuvant therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (ACTUAL): November 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: neoadjuvant; Apatinib; thyroid cancer; locally advanced; Camrelizumab
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: CALA-TC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No