RecruitingPhase 2NCT06482086

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


Sponsor

West China Hospital

Enrollment

75 participants

Start Date

Jun 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria19

  • \. 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:
  • Papillary thyroid carcinoma (PTC)
  • Follicular thyroid carcinoma (FTC)
  • Medullary thyroid carcinoma (MTC)
  • Poorly differentiated thyroid carcinoma (PDTC)
  • Anaplastic thyroid carcinoma (ATC)
  • \. 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:
  • Vocal cord paralysis by fiberoptic examination
  • 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
  • Extension into the mediastinum with visceral and/or vascular involvement
  • Involvement of the carotid artery or other major vessel by 180 degrees or more
  • Other factors that make the participant to be "at risk for R2 resection" may be allowed, after discussion with the study's principal investigator.
  • \. There is at least one measurable lesion according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
  • \. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
  • \. Normal organ and bone marrow function.
  • \. Adequate end-organ function (including bone marrow, coagulation, renal, liver and cardiac) 28 days prior to the study registration.
  • \. Ability to swallow pills.
  • \. Signed informed consent form.
  • \. Expected survival time of more than 2 months.

Exclusion Criteria7

  • \. Patients with contraindications specified in the drug instructions for the targeted drugs involved in the corresponding organoid drug sensitivity tests.
  • \. Patients with incomplete clinical data.
  • \. Patients with severe organ dysfunction, metabolic diseases, or other conditions significantly affecting survival.
  • \. Other active malignant disease requiring therapy.
  • \. Females who are pregnant or breastfeeding.
  • \. Patients without target lesions.
  • \. Patients deemed unsuitable for inclusion by the researchers.

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Interventions

DRUGAnlotinib

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

DRUGLenvatinib

8/12 mg qd, po.

DRUGSorafenib

0.4 g bid, po.

DRUGDonafenib

0.3 g bid, po.

DRUGEverolimus

10 mg qd, po.

DRUGApatinib

500 mg qd, po.

DRUGDabrafenib + Trametinib

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

DRUGCabozantinib

Cabozantinib 60mg qd, po.

DRUGVandetanib

Vandetanib 300mg qd, po.

DRUGEntrectinib

Entrectinib 600mg qd,po.

DRUGPralsetinib

400mg qd, po.

DRUGLarotrectinib

100mg qd,po


Locations(1)

West China hospital

Chengdu, Sichuan, China

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NCT06482086