NCT06482086 Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer
| NCT ID | NCT06482086 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | West China Hospital |
| Condition | Locally Advanced Thyroid Gland Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2021-06-01 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The current study aims to explore the potential advantages of anti-cancer therapy that is implemented based on drug sensitivity testing. This pertains to individuals with locally advanced thyroid cancer who have undergone conventional therapy in the past or unresectable patients .
Eligibility Criteria
Inclusion Criteria: * 1\. Adult participants who have either been initially diagnosed with locally advanced thyroid cancer or have experienced persistent or recurrent thyroid cancer, including cervical nodal recurrence. Types of pathology include: 1. Papillary thyroid carcinoma (PTC) 2. Follicular thyroid carcinoma (FTC) 3. Medullary thyroid carcinoma (MTC) 4. Poorly differentiated thyroid carcinoma (PDTC) 5. Anaplastic thyroid carcinoma (ATC) * 2\. Evidence of extrathyroidal extension and/or locally invasive disease and deemed at risk for R2 resection by treating team on clinical and/or fiberoptic examination and/or radiographic evaluation in the primary or recurrent setting. Evidence of "at risk for R2 resection" includes: 1. Vocal cord paralysis by fiberoptic examination 2. Extrathyroid and/or extranodal extension on CT or MRI, including tracheal and/or laryngeal cartilage invasion, esophageal involvement, and/or involvement of perithyroid muscles (e.g. strap, sternocleidomastoid, inferior constrictor muscles) or bone involvement 3. Extension into the mediastinum with visceral and/or vascular involvement 4. Involvement of the carotid artery or other major vessel by 180 degrees or more 5. Other factors that make the participant to be "at risk for R2 resection" may be allowed, after discussion with the study's principal investigator. * 3\. There is at least one measurable lesion according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST). * 4\. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2. * 5\. Normal organ and bone marrow function. * 6\. Adequate end-organ function (including bone marrow, coagulation, renal, liver and cardiac) 28 days prior to the study registration. * 7\. Ability to swallow pills. * 8\. Signed informed consent form. * 9\. Expected survival time of more than 2 months. Exclusion Criteria: * 1\. Patients with contraindications specified in the drug instructions for the targeted drugs involved in the corresponding organoid drug sensitivity tests. * 2\. Patients with incomplete clinical data. * 3\. Patients with severe organ dysfunction, metabolic diseases, or other conditions significantly affecting survival. * 4\. Other active malignant disease requiring therapy. * 5\. Females who are pregnant or breastfeeding. * 5\. Patients without target lesions. * 6\. Patients deemed unsuitable for inclusion by the researchers.
Contact & Investigator
Zhihui Li, Professor
STUDY DIRECTOR
West China Hospital
Frequently Asked Questions
Who can join the NCT06482086 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Thyroid Gland Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06482086 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06482086 currently recruiting?
Yes, NCT06482086 is actively recruiting participants. Contact the research team at rockoliver@vip.sina.com for enrollment information.
Where is the NCT06482086 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06482086 clinical trial?
NCT06482086 is sponsored by West China Hospital. The principal investigator is Zhihui Li, Professor at West China Hospital. The trial plans to enroll 75 participants.