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NCT06482086RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 5 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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 .

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
75 (estimated)
First submitted
15 Jun 2024
Start date
1 Jun 2021
Primary completion date
1 Dec 2024
Lead sponsor
West China Hospital
NCT number
NCT06482086

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 75
  • From 1 Jun 2021 to the primary completion date, 1 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 1\. Patients with contraindications specified in the drug instructions for the targeted drugs involved in the corresponding organoid drug sensitivity tests.

Other illness

  • 3\. Patients with severe organ dysfunction, metabolic diseases, or other conditions significantly affecting survival.
  • 4\. Other active malignant disease requiring therapy.

Other

  • 2\. Patients with incomplete clinical data.
  • 5\. Females who are pregnant or breastfeeding.
  • 5\. Patients without target lesions.
  • 6\. Patients deemed unsuitable for inclusion by the researchers.

Who the study is looking for

  • 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:
    • Papillary thyroid carcinoma (PTC)
    • Follicular thyroid carcinoma (FTC)
    • Medullary thyroid carcinoma (MTC)
    • Poorly differentiated thyroid carcinoma (PDTC)
    • 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:
    • 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.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
West China Hospital
Coordinator of this site? Confirm its status
ChengduChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.