Recruiting PHASE2 Locally Advanced Thyroid Gland Carcinoma

Tests treatment safety and results for Locally Advanced Thyroid Gland Carcinoma

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

ClinicalTrials.gov ID: NCT06482086

What this study is testing

What is Anlotinib?

Anlotinib is an investigational medicine, being studied as a potential treatment for locally advanced thyroid gland carcinoma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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 .
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 1\. Adult participants who have either been initially diagnosed with locally advanced thyroid cancer or have experienced persistent or recurrent...
  • Papillary thyroid carcinoma (PTC)
  • Follicular thyroid carcinoma (FTC)
  • Medullary thyroid carcinoma (MTC)
  • Poorly differentiated thyroid carcinoma (PDTC)

You likely can't join if

  • 1\. Patients with contraindications specified in the drug instructions for the targeted drugs involved in the corresponding organoid drug sensitivity...
  • 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.
See the full eligibility criteria
Who can join
  • 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...
  • 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...
  • 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...
  • 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.
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Chengdu, Sichuan, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.