Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT07010393
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years at enrollment.
2. Histologically or cytologically confirmed thyroid carcinoma that meets ≥ 1 of the following:
* Radioactive-iodine-refractory differentiated thyroid carcinoma (DTC)
* Medullary thyroid carcinoma (MTC)
* Anaplastic or poorly differentiated thyroid carcinoma (ATC/PDTC)
* Other locally advanced / metastatic thyroid malignancy deemed incurable by surgery alone.
3. Disease judged unresectable or entailing prohibitively high-morbidity surgery at baseline by a multidisciplinary thyroid-oncology board.
4. Documented molecular or immunophenotype qualifying for ≥ 1 study arm:
* BRAF V600E mutation
* RET gene fusion
* RET activating point mutation (e.g., M918T)
* NTRK1/2/3 fusion
* Isolated TERT-promoter mutation with no BRAF/RET/NTRK alterations
* Driver-negative / VEGFR-wild type ("triple-negative")
* PD-L1 expression ≥ 1 % OR progression after prior multi-kinase inhibitor (MKI).
5. ECOG Performance Status 0-2.
6. At least one measurable lesion per RECIST v1.1 / iRECIST (MTC with calcitonin/CEA evaluable disease accepted).
7. Written informed consent obtained.
Exclusion Criteria:
1. Untreated or symptomatic CNS metastases; patients with treated, stable lesions ≥ 4 weeks and off corticosteroids are eligible.
2. Pregnant or breastfeeding. Women and men of child-bearing potential must agree to effective contraception during study and for ≥ 120 days after last dose (≥ 180 days for men after dabrafenib/trametinib).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07010393
Study Brief:
Protocol Section:
NCT07010393