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RECRUITINGPhase 2INTERVENTIONAL

Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer

Precision Medicine Applied to Locally Advanced Thyroid Cancer Using Tumor-derived Organoids and In-vitro Sensitivity Testing: a Phase 2a, Single-center, Open-label, and Non-comparative Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 .

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form. - 9\. Expected survival time of more than 2 months. Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Anlotinib

8/10/12 mg qd, po. Stop the medication for one week after taking it for two weeks.

DRUG

Lenvatinib

8/12 mg qd, po.

DRUG

Sorafenib

0.4 g bid, po.

DRUG

Donafenib

0.3 g bid, po.

DRUG

Everolimus

10 mg qd, po.

DRUG

Apatinib

500 mg qd, po.

DRUG

Dabrafenib + Trametinib

Dabrafenib 150 mg bid, po+Trametinib 2 mg qd, po.

DRUG

Cabozantinib

Cabozantinib 60mg qd, po.

DRUG

Vandetanib

Vandetanib 300mg qd, po.

DRUG

Entrectinib

Entrectinib 600mg qd,po.

DRUG

Pralsetinib

400mg qd, po.

DRUG

Larotrectinib

100mg qd,po

Locations (1)

West China hospital
Chengdu, Sichuan, China