Multiple Target Kinase Inhibitor and Anti-Programmed Death-1 Antibody in Patients With Advanced Thyroid Cancer
Multiple Target Kinase Inhibitor and Anti-Programmed Death-1 Antibody in Patients With Advanced Thyroid Cancer
Brief 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.
Detailed 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 Type: Interventional (Clinical Trial)
Estimated Enrollment: 115 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date: December 30, 2019
Estimated Primary Completion Date: June 30, 2022
Estimated Study Completion Date: June 30, 2023
Arm:
- Experimental: RAIR-DTC arm
- Experimental: MTC arm
- Experimental: ATC arm
- Experimental: DTC unsuitable for RAI arm
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 115 |
| Actual Study start date | 30 December 2019 |
| Estimated Study Completion Date | 30 June 2023 |