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Multiple Target Kinase Inhibitor and Anti-Programmed Death-1 Antibody in Patients With Advanced Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:
A Phase II Study to Explore the Safety and Efficacy of Multiple Target Kinase Inhibitor(mTKI) Combined With Anti-Programmed Death-1(PD-1) Antibody in the Treatment of Advanced Thyroid Cancer

Clinical Trial Summary

The study is being conducted to evaluate the safety and efficacy of Multiple Target Kinase Inhibitor(mTKI) Combined with Anti-Programmed Death-1(PD-1) Antibody in subjects with advanced thyroid cancer.

Clinical Trial Description

We will recruit four types of advanced thyroid cancer patients. Arm A will enroll the radioactive Iodine-refractory differentiated thyroid cancer(RAIR-DTC). Arm B will recruit the advanced medullary thyroid cancer(MTC). Arm C will include the advanced anaplastic thyroid cancer(ATC). Arm D will include the differentiated thyroid cancer that unsuitable for 131I treatment. This clinical trial will be conducted under Simon's optimal two-stage design. For arm A, the first stage needs 8 participants, if 4 or more participants acquire remission, the study will move on to the second stage and enroll another 16 patients to achieve a total number of 24 participants enrolled. For arm B, the first stage needs 8 participants, if 4 or more participants acquire remission, the study will move on to the second stage and enroll another 16 patients to achieve a total number of 24 participants enrolled. For arm C, the first stage needs 13 participants, if 4 or more participants acquire remission, the study will move on to the second stage and enroll another 30 patients to achieve a total number of 43 participants enrolled. For arm D, the first stage needs 8 participants, if 4 or more participants acquire remission, the study will move on to the second stage and enroll another 16 patients to achieve a total number of 24 participants enrolled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04521348
Study type Interventional
Source Fudan University
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 30, 2019
Completion date June 30, 2024
View Details
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