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

Phase 2

Recruiting

• Conditions: Locally Advanced Thyroid Gland Carcinoma
• Interventions: Drug: Anlotinib; Drug: Lenvatinib; Drug: Sorafenib; Drug: Donafenib; Drug: Everolimus; Drug: Apatinib; Drug: Dabrafenib + Trametinib; Drug: Cabozantinib; Drug: Vandetanib; Drug: Entrectinib; Drug: Pralsetinib; Drug: Larotrectinib

• Registration Number: NCT06482086
• Lead Sponsor: West China Hospital

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 .

Detailed Description

This research trial aims to determine the efficacy of organoid-guided targeted therapy for patients with locally advanced thyroid cancer. We will also investigate the variables affecting the effectiveness of targeted therapy for locally advanced thyroid cancer that is guided by organoids. Additionally, side effects related to the medication are also studied....

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2024-06-15
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-07-01
• Status Verified: 2024-12
• Primary Completion: 2024-12-01
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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:

  2. Papillary thyroid carcinoma (PTC)

  3. Follicular thyroid carcinoma (FTC)

  4. Medullary thyroid carcinoma (MTC)

  5. Poorly differentiated thyroid carcinoma (PDTC)

  6. 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:

  3. Vocal cord paralysis by fiberoptic examination

  4. 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

  5. Extension into the mediastinum with visceral and/or vascular involvement

  6. Involvement of the carotid artery or other major vessel by 180 degrees or more

  7. 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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Organoid-guided targeted therapeutic group	Anlotinib	Patients who take the recommended drugs regularly based on sensitivity analysis.
Organoid-guided targeted therapeutic group	Donafenib	Patients who take the recommended drugs regularly based on sensitivity analysis.
Organoid-guided targeted therapeutic group	Dabrafenib + Trametinib	Patients who take the recommended drugs regularly based on sensitivity analysis.
Organoid-guided targeted therapeutic group	Sorafenib	Patients who take the recommended drugs regularly based on sensitivity analysis.
Organoid-guided targeted therapeutic group	Lenvatinib	Patients who take the recommended drugs regularly based on sensitivity analysis.
Organoid-guided targeted therapeutic group	Everolimus	Patients who take the recommended drugs regularly based on sensitivity analysis.
Organoid-guided targeted therapeutic group	Cabozantinib	Patients who take the recommended drugs regularly based on sensitivity analysis.
Organoid-guided targeted therapeutic group	Pralsetinib	Patients who take the recommended drugs regularly based on sensitivity analysis.
Organoid-guided targeted therapeutic group	Apatinib	Patients who take the recommended drugs regularly based on sensitivity analysis.
Organoid-guided targeted therapeutic group	Vandetanib	Patients who take the recommended drugs regularly based on sensitivity analysis.
Organoid-guided targeted therapeutic group	Entrectinib	Patients who take the recommended drugs regularly based on sensitivity analysis.
Organoid-guided targeted therapeutic group	Larotrectinib	Patients who take the recommended drugs regularly based on sensitivity analysis.

Primary Outcome Measures

Name	Time	Method
Progress-free survival	Every 8 weeks until progression or death up to 3 years	PFS is defined as the time from the administration of the first dose to first disease progression or death.
Objective response rate	Every 8 weeks until progression up to 3 years	ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Overall R0/R1 resection rate	Up to 36 months.	Defined as the proportion of patients who undergo R0/R1 resection among all patients.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to 36 months.	OS is defined as the time from the administration of the first dose to death.
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0	Up to 36 months
Change in Surgical complexity and morbidity score (SCMS)	Up to 36 months	The Thyroid Neck Group Morbidity Complexity Scoring and MGH/MEE-MSK-MD Anderson (MMM) Surgical Morbidity Complexity Score (SMCS) are incorporated, specifying on scale with 5 levels of complexity and morbidity of the surgery \[mild (level 0), moderate (level 1), severe (level 2), very severe (level 3), and unresectable (level 4)\]. The surgical morbidity/comp...

Trial Locations

Locations (1)

West China hospital; 🇨🇳 Chengdu, Sichuan, China