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
1 other identifier
interventional
75
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2021
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
June 15, 2024
CompletedFirst Posted
Study publicly available on registry
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedDecember 5, 2024
December 1, 2024
3.5 years
June 15, 2024
December 2, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Objective response rate
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)
Every 8 weeks until progression up to 3 years
Progress-free survival
PFS is defined as the time from the administration of the first dose to first disease progression or death.
Every 8 weeks until progression or death up to 3 years
Overall R0/R1 resection rate
Defined as the proportion of patients who undergo R0/R1 resection among all patients.
Up to 36 months.
Secondary Outcomes (3)
Overall Survival
Up to 36 months.
Change in Surgical complexity and morbidity score (SCMS)
Up to 36 months
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0
Up to 36 months
Study Arms (1)
Organoid-guided targeted therapeutic group
EXPERIMENTALPatients who take the recommended drugs regularly based on sensitivity analysis.
Interventions
8/10/12 mg qd, po. Stop the medication for one week after taking it for two weeks.
Dabrafenib 150 mg bid, po+Trametinib 2 mg qd, po.
Eligibility Criteria
You may qualify if:
- \. 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.
- +4 more criteria
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China hospital
Chengdu, Sichuan, 610041, China
Related Publications (1)
Guo Z, Liu J, Zhang X, Ma Y, Wang Y, Li P, Huang R, Li Z; MDT of Advanced Thyroid Cancer of West China Hospital. Precision treatment guided by patient-derived organoids-based drug testing for locally advanced thyroid cancer: a single arm, phase 2 study. Endocrine. 2025 Jul;89(1):186-196. doi: 10.1007/s12020-025-04240-9. Epub 2025 Apr 30.
PMID: 40304938DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhihui Li, Professor
West China Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean of the Thyroid Surgery Department
Study Record Dates
First Submitted
June 15, 2024
First Posted
July 1, 2024
Study Start
June 1, 2021
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
December 5, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share