Efficacy of Organoid-Based Chemotherapy Drug Precision Screening to Guide Treatment for Thyroid Cancer
NCT ID: NCT06713057
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2024-12-01
2026-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Currently, there are numerous clinical trials evaluating various molecularly targeted therapies for refractory, poorly differentiated thyroid cancer. Preoperative personalized targeted neoadjuvant therapy has been established as a critical approach in managing advanced thyroid cancer. However, clinical trials investigating personalized chemotherapy to guide the treatment of thyroid cancer remain scarce.
Tumor organoids represent a sophisticated three-dimensional pathological model that preserves the histological and molecular characteristics of the original tumor. These models can be utilized to assess the in vitro efficacy of multiple anticancer drugs. The investigators' objective is to validate the effectiveness and safety of selecting and processing chemotherapeutic agents through drug susceptibility testing, thereby ensuring pragmatic and precise treatment tailored to individual patients' needs.
The investigators will also investigate the variables affecting the effectiveness of chemotherapy that is guided by organoids. Additionally, side effects related to the medication are also studied.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Organoid-guided chemotherapeutic group
Patients who take the recommended chemothetapy drugs regularly based on sensitivity analysis.
Cyclophosphamide+Pemetrexed+5-Fluorouracil
IV or PO
Cyclophosphamide+Doxorubicin+5-Fluorouracil
IV or PO
Vindesine + Cisplatin
IV or PO
Doxorubicin + Cisplatin
IV or PO
Doxorubicin + Cyclophosphamide + Cisplatin
IV or PO
Docetaxel + Doxorubicin
IV or PO
Paclitaxel + Carboplatin
IV or PO
Paclitaxel + Doxorubicin
IV or PO
Paclitaxel + Cisplatin
IV or PO
Gemcitabine alone
IV or PO
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cyclophosphamide+Pemetrexed+5-Fluorouracil
IV or PO
Cyclophosphamide+Doxorubicin+5-Fluorouracil
IV or PO
Vindesine + Cisplatin
IV or PO
Doxorubicin + Cisplatin
IV or PO
Doxorubicin + Cyclophosphamide + Cisplatin
IV or PO
Docetaxel + Doxorubicin
IV or PO
Paclitaxel + Carboplatin
IV or PO
Paclitaxel + Doxorubicin
IV or PO
Paclitaxel + Cisplatin
IV or PO
Gemcitabine alone
IV or PO
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Cytologically confirmed thyroid neoplasm, including papillary thyroid carcinoma (PTC), follicular thyroid carcinoma (FTC), poorly differentiated thyroid carcinoma (PDTC), medullary thyroid carcinoma (MTC), anaplastic thyroid carcinoma (ATC)
3. Patients defined as poorly differentiated iodine-refractory thyroid tumors with inoperable locally advanced disease or metastases. The primary tumor may or may not be removed, but the risk of aerodigestive compression or bleeding should be excluded.
4. 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:
1. Vocal cord paralysis by fiberoptic examination
2. 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
3. Extension into the mediastinum with visceral and/or vascular involvement
4. Involvement of the carotid artery or other major vessel by 180 degrees or more (exclusive of complete encasement)
5. Other factors that make the participant to be "at risk for R2 resection" may be allowed, after discussion with the study's principal investigator
5. At least one measurable lesion as defined by RECIST v1.1
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and no medical contraindication to surgery
7. Surgical morbidity/complexity score of 1 to 4 (moderate, severe, very severe, or unresectable)
8. The expected survival time was more than 2 months
9. Adequate end-organ function (including bone marrow, coagulation, renal, liver and cardiac) 28 days prior to the study registration as defined below:
1. leukocytes ≥3,000/mcL
2. absolute neutrophil count ≥1,500/mcL
3. platelets ≥100,000/mcL
4. hemoglobin ≥ 9 g/dL (5.58 mmol/L)
5. total bilirubin ≤1.5 x institutional upper limit of normal, unless attributed to Gilberts syndrome
6. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) \< 2.5 x institutional upper limit of normal
7. INR ≤1.5 x institutional upper limit of normal
8. creatinine within normal institutional limits OR
9. creatinine clearance ≥30 mL/min per Cockcroft-Gault formulation
10. normal serum potassium, calcium, and magnesium levels (may be receiving supplements). Grade 1 hypocalcemia (corrected serum calcium \> 8) is acceptable
10. Willing to undergo tumor biopsy prior to trial treatment, unless in the opinion of the treating physician, a biopsy is not feasible or safe. Subjects must be willing to ultimately undergo surgery if their tumor becomes surgically resectable
11. Ability to comply with outpatient treatment, laboratory monitoring, and require clinic visits for the duration of study participation
12. Willing and able to provide written informed consent signed by study patient (or legally acceptable representative if applicable)
13. Willingness of patients with partners of childbearing potential to use a highly effective contraceptive method during treatment with study drug and for 3 months following the last dose of study drug
Exclusion Criteria
2. Patients with contraindications to the involved chemotherapy drugs (such as severe coagulopathy, severe liver function impairment, etc.)
3. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment
4. Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of study drug
5. Patients with serious internal medicine underlying diseases, serious organ dysfunction, metabolic diseases or other diseases that seriously affect survival
6. If \> 1 + proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥1g/24 h will be ineligible
7. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment
8. Active hemoptysis (bright red blood ≥ 1/2 teaspoon) or other uncontrolled bleeding within 21 days prior to the study registration
9. Arterial/venous thromboembolic events in the last 12 months Treatment within 30 days prior to study registration with anticoagulant or antiplatelet therapy, apart from aspirin 81 mg daily
10. Active uncontrolled systemic bacterial, viral, or fungal infection, or serious ongoing intercurrent illness
11. Uncontrolled symptomatic hyperthyroidism or hypothyroidism
12. Females who are pregnant or breastfeeding
13. Other progressive malignant diseases requiring treatment
14. Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study treatment
15. Symptomatic primary central nervous system (CNS) tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Exception: Patients are eligible if neurological symptoms and CNS imaging are stable and no CNS surgery or radiation has been performed for 28 days, 14 days if stereotactic radiosurgery (SRS)
16. Patients with incomplete clinical data
17. History of significant neurological or mental disorder, including seizures or dementia, which would interfere compliance and sign of consent inform
18. Patients deemed unsuitable for inclusion by the investigators
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
West China Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Li Zhihui
Dean of the Thyroid Surgery Department
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
West China hospital
Chengdu, Sichuan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HX20231471
Identifier Type: -
Identifier Source: org_study_id