NCT04612894

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

October 30, 2020

Last Update Submit

November 2, 2020

Conditions

Thyroid Cancer

Keywords

thyroid cancerlocally advancedneoadjuvantCamrelizumabApatinib

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    ORR

    up to 24 weeks

Secondary Outcomes (4)

  • R0/1 resection rate

    at the time of surgery

  • Disease control rate

    at the time point of 6 weeks

  • Overall survival

    up to 3 years

  • Adverse Events

    from the first drug administration to within 90 days after surgery

Study Arms (1)

Neoadjuvant Camrelizumab + Apatinib

EXPERIMENTAL

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 ApatinibProcedure: surgeryProcedure: core needle biopsy

Interventions

Camrelizumab and ApatinibDRUG

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

Neoadjuvant Camrelizumab + Apatinib
surgeryPROCEDURE

Perform surgery if operable after neoadjuvant therapy

Neoadjuvant Camrelizumab + Apatinib
core needle biopsyPROCEDURE

Perform core needle biopsy if inoperable after neoadjuvant therapy

Neoadjuvant Camrelizumab + Apatinib

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

camrelizumabapatinibSurgical Procedures, OperativeBiopsy, Large-Core Needle

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Biopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalPuncturesInvestigative Techniques

Central Study Contacts

Yu Wang, M.D.

CONTACT

86-021-64175590neck130@hotmail.com

Nai-si Huang, M.D.

CONTACT

86-021-64175590huangnaisi@fudan.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 3, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 31, 2023

Last Updated

November 3, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)