Efficacy of Organoid-Based Chemotherapy Drug Precision Screening to Guide Treatment for Thyroid Cancer

NCT06713057 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: HX20231471
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to explore the potential advantages of chemotherapy that is implemented based on drug sensitivity testing. This pertains to individuals with locally advanced or metastatic poorly differentiated or anaplastic thyroid cancer who have undergone conventional therapy in the past or unresectable patients .

Conditions

Locally Advanced Thyroid Gland Carcinoma; Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  To evaluate the efficacy of chemotherapy per RECIST (standard Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]), the percentages of patients will report that fall into each of the four categories: complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)

  Every 2 months until 12 months

Secondary Outcomes (5)

• Progression free survival (PFS)

  Up to 2 years post treatment

• Overall survival (OS)

  Up to 2 years post treatment

• R0/R1 resection rates

  From the date of enrollment to the date of surgery, up to 12 months

• Incidence of adverse events

  Every 2 months until 12 months

• Quality of life

  Every 2 months until 12 months

Study Arms (1)

Organoid-guided chemotherapeutic group

EXPERIMENTAL

Patients who take the recommended chemothetapy drugs regularly based on sensitivity analysis.

Drug: Cyclophosphamide+Pemetrexed+5-Fluorouracil; Drug: Cyclophosphamide+Doxorubicin+5-Fluorouracil; Drug: Vindesine + Cisplatin; Drug: Doxorubicin + Cisplatin; Drug: Doxorubicin + Cyclophosphamide + Cisplatin; Drug: Docetaxel + Doxorubicin; Drug: Paclitaxel + Carboplatin; Drug: Paclitaxel + Doxorubicin; Drug: Paclitaxel + Cisplatin; Drug: Gemcitabine alone

Interventions

Cyclophosphamide+Pemetrexed+5-Fluorouracil DRUG

IV or PO

Organoid-guided chemotherapeutic group

Cyclophosphamide+Doxorubicin+5-Fluorouracil DRUG

IV or PO

Organoid-guided chemotherapeutic group

Vindesine + Cisplatin DRUG

IV or PO

Organoid-guided chemotherapeutic group

Doxorubicin + Cisplatin DRUG

IV or PO

Organoid-guided chemotherapeutic group

Doxorubicin + Cyclophosphamide + Cisplatin DRUG

IV or PO

Organoid-guided chemotherapeutic group

Docetaxel + Doxorubicin DRUG

IV or PO

Organoid-guided chemotherapeutic group

Paclitaxel + Carboplatin DRUG

IV or PO

Organoid-guided chemotherapeutic group

Paclitaxel + Doxorubicin DRUG

IV or PO

Organoid-guided chemotherapeutic group

Paclitaxel + Cisplatin DRUG

IV or PO

Organoid-guided chemotherapeutic group

Gemcitabine alone DRUG

IV or PO

Organoid-guided chemotherapeutic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age on the day of signing informed consent
• 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)
• 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.
• 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 (exclusive of complete encasement)
• Other factors that make the participant to be "at risk for R2 resection" may be allowed, after discussion with the study's principal investigator
• At least one measurable lesion as defined by RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and no medical contraindication to surgery
• Surgical morbidity/complexity score of 1 to 4 (moderate, severe, very severe, or unresectable)
• The expected survival time was more than 2 months
• Adequate end-organ function (including bone marrow, coagulation, renal, liver and cardiac) 28 days prior to the study registration as defined below:
• leukocytes ≥3,000/mcL

You may not qualify if:

• Radiographically identified following findings: intraluminal airway tumor, complete carotid encasement/infiltration
• Patients with contraindications to the involved chemotherapy drugs (such as severe coagulopathy, severe liver function impairment, etc.)
• Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment
• Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of study drug
• Patients with serious internal medicine underlying diseases, serious organ dysfunction, metabolic diseases or other diseases that seriously affect survival
• 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
• 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
• Active hemoptysis (bright red blood ≥ 1/2 teaspoon) or other uncontrolled bleeding within 21 days prior to the study registration
• 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
• Active uncontrolled systemic bacterial, viral, or fungal infection, or serious ongoing intercurrent illness
• Uncontrolled symptomatic hyperthyroidism or hypothyroidism
• Females who are pregnant or breastfeeding
• Other progressive malignant diseases requiring treatment
• 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
• 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)

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Vindesine; Cisplatin; Doxorubicin; Cyclophosphamide; Docetaxel; CP protocol; Paclitaxel; TP protocol; Gemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Zhihui Li, Professor

CONTACT

18980602027; rockoliver@vip.sina.com

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: November 25, 2024
• First Posted: December 3, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)