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Locally Advanced Thyroid Gland CarcinomaPhase 2NCT06713057

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

A Phase 2 study testing Cyclophosphamide+Pemetrexed+5-Fluorouracil, Cyclophosphamide+Doxorubicin+5-Fluorouracil and Vindesine + Cisplatin in people with Locally Advanced Thyroid Gland Carcinoma and Thyroid Cancer, run by West China Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cyclophosphamide+Pemetrexed+5-Fluorouracil, Cyclophosphamide+Doxorubicin+5-Fluorouracil and Vindesine + Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Dec 2024to 1 Jul 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • absolute neutrophil count ≥1,500/mcL
  • platelets ≥100,000/mcL
  • hemoglobin ≥ 9 g/dL (5.58 mmol/L)
  • total bilirubin ≤1.5 x institutional upper limit of normal, unless attributed to Gilberts syndrome
  • Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) < 2.5 x institutional upper limit of normal
  • INR ≤1.5 x institutional upper limit of normal
  • creatinine within normal institutional limits OR
  • creatinine clearance ≥30 mL/min per Cockcroft-Gault formulation
  • normal serum potassium, calcium, and magnesium levels (may be receiving supplements). Grade 1 hypocalcemia (corrected serum calcium > 8) is acceptable
  • 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
  • Ability to comply with outpatient treatment, laboratory monitoring, and require clinic visits for the duration of study participation
  • Willing and able to provide written informed consent signed by study patient (or legally acceptable representative if applicable)
  • 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

Who cannot join

  • 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
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  • 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)
  • Patients with incomplete clinical data
  • History of significant neurological or mental disorder, including seizures or dementia, which would interfere compliance and sign of consent inform
  • Patients deemed unsuitable for inclusion by the investigators

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhihui Li, Professor contact

18980602027 ext. +86

rockoliver@vip.sina.com

China1 site

  • West China hospital

    Chengdu, Sichuan, 610041

    Zhihui Li, Professor, 18980602027 ext. +86, rockoliver@vip.sina.com

Other trials in China

About this study

Official title: Precision Medicine Applied to Locally Advanced or Metastatic Poorly Differentiated or Anaplastic Thyroid Cancer Using Tumor Derived Organoids and In-vitro Sensitivity Testing: a Phase 2, Single-center, Open-label, and Non-comparative Study

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 .

Read the detailed description

This research trial aims to determine the efficacy of organoid-guided chemotherapy for patients with locally advanced or metastatic poorly differentiated or anaplastic thyroid cancer.

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.

Being tested
Cyclophosphamide+Pemetrexed+5-Fluorouracil, Cyclophosphamide+Doxorubicin+5-Fluorouracil, Vindesine + Cisplatin, Doxorubicin + Cisplatin, Doxorubicin + Cyclophosphamide + Cisplatin
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cyclophosphamide+Pemetrexed+5-FluorouracilDrug

    IV or PO

  • Cyclophosphamide+Doxorubicin+5-FluorouracilDrug

    IV or PO

  • Vindesine + CisplatinDrug

    IV or PO

  • Doxorubicin + CisplatinDrug

    IV or PO

  • Doxorubicin + Cyclophosphamide + CisplatinDrug

    IV or PO

  • Docetaxel + DoxorubicinDrug

    IV or PO

  • Paclitaxel + CarboplatinDrug

    IV or PO

  • Paclitaxel + DoxorubicinDrug

    IV or PO

  • Paclitaxel + CisplatinDrug

    IV or PO

  • Gemcitabine aloneDrug

    IV or PO

Study groups in NCT06713057
Study groupRoleWhat they receive
Organoid-guided chemotherapeutic groupExperimentalPatients who take the recommended chemothetapy drugs regularly based on sensitivity analysis.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Every 2 months until 12 months

Secondary outcomes (5)

  1. Progression free survival (PFS)

    Defined as the time from patient registration to disease progression or death from any cause. Structural progression is defined according to RECIST criteria based on histopathologic findings, and biochemical progression is defined as abnormal thyroglobulin (Tg) or rising Tg antibody levels for anaplastic thyroid cancer/differentiated thyroid cancer, and abnormal carcinoembryonic antigen/calcitonin for medullary thyroid cancer

    Measured: Up to 2 years post treatment

  2. Overall survival (OS)

    Defined as the time from patient registration to death from any causes

    Measured: Up to 2 years post treatment

  3. R0/R1 resection rates

    Defined by proportion of patients who undergo successful thyroidectomy with clear (R0) or microscopically positive (R1) surgical margins. Will evaluate R0/R1 resection rates in each of 4 pre-specified extrathyroidal anatomic target interfaces: 1) perithyroid muscles (e.g. strap, sternocleidomastoid, inferior constrictor muscles) 2) cartilage (larynx/trachea) 3) esophagus 4) recurrent laryngeal nerve

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

  4. Incidence of adverse events

    Assessed as defined by Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

    Measured: Every 2 months until 12 months

  5. Quality of life

    Assessed by the European Quality of Life 5 Dimension Questionnaire (EQ-5D). The EQ-5D consists of health state description and evaluation. The health state description consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), with each dimension specifying five levels of severity [best (1)-worst (5)]. The health state evaluation is assessed using the visual analogue scale ([worse (0)-best (100)]

    Measured: Every 2 months until 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2024
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06713057
Sponsor's protocol ID
HX20231471
Status last verified
Dec 2024
First submitted
25 Nov 2024
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide+Pemetrexed+5-Fluorouracil, Cyclophosphamide+Doxorubicin+5-Fluorouracil and Vindesine + Cisplatin in people with Locally Advanced Thyroid Gland Carcinoma and Thyroid Cancer, run by West China Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhihui Li, Professor (18980602027 ext. +86, rockoliver@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Every 2 months until 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06713057.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

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