Multiple Target Kinase Inhibitor and Anti-Programmed Death-1 Antibody in Patients With Advanced Thyroid Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 91
Summary
- Conditions
- Thyroid Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 inclu...
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.
Tracking Information
- NCT #
- NCT04521348
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: JI DONGMEI, M.D Fudan University