RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer

July 31, 2024 updated by: Yu Wang, Fudan University

The Efficacy and Safety of RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer: a Real-world Study

This study is a multicenter observational study. Patients receive neoadjuvant therapy with RET inhibitors in the real world, and those who can undergo surgery after neoadjuvant therapy receive surgical treatment. The aim of the study is to determine the efficacy and safety of RET inhibitors for neoadjuvant therapy in locally advanced RET-altered thyroid cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Fudan Univeristy Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with locally advanced thyroid cancer and RET alterations, who require RET inhibitor treatment and surgery after neoadjuvant therapy.

Description

Inclusion Criteria:

  • Patients voluntarily join this study and sign an informed consent form;
  • Age: ≥ 14 years old, male or female not limited;
  • Locally advanced thyroid cancer diagnosed by histopathology, including papillary thyroid carcinoma, medullary thyroid carcinoma, follicular thyroid carcinoma, poorly differentiated/poorly differentiated thyroid carcinoma, etc;
  • RET alterations, including fusion and mutations;

  • The definition of locally advanced thyroid cancer meets at least one of the following criteria:

    1. Local advanced thyroid cancer with estimated surgical difficulty and inability to R0/1 resection;
    2. T4 thyroid cancer defined by AJCC: any size of tumor primary lesion or regional lymph node infiltration beyond the thyroid capsule to subcutaneous soft tissue, larynx, trachea, esophagus, or recurrent laryngeal nerve, tumor invasion of pre vertebral fascia or wrapping around carotid or mediastinal blood vessels;
    3. According to the imaging score, the resectable probability is less than 80% based on CT.
  • At least one measurable lesion;
  • For patients with distant metastasis, researchers need to determine whether patients would benefit from surgery;
  • Patients voluntarily undergo tumor tissue biopsy/surgery during enrollment and withdrawal;
  • Normal function of major organs.

Exclusion Criteria:

  • Previously used RET inhibitors;
  • There are multiple factors that affect the absorption of oral medication, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction;
  • The patient refuses to undergo tumor tissue biopsy or surgery;
  • Patients who are unsuitable for RET inhibitors or surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
None MTC
DTC, PDTC and ATC patients with RET fusions.
Drug: RET Inhibitor
RET inhibitors for neoadjuvant treatment
Procedure: Surgery
Operable patients receive surgery after neoadjuvant therapy
MTC
MTC patients with RET mutations
Drug: RET Inhibitor
RET inhibitors for neoadjuvant treatment
Procedure: Surgery
Operable patients receive surgery after neoadjuvant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
R0/1 resection rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate, ORR
Time Frame: 1 year
1 year
Disease Control Rate，DCR
Time Frame: 1 year
1 year
Time to objective response，TTR
Time Frame: 1 year
1 year
Progression Free Survival，PFS
Time Frame: 5 years
5 years
Overall Survival，OS
Time Frame: 5 years
5 years
Adverse Events
Time Frame: During RET inhibitor treatment, up to 5 years
During RET inhibitor treatment, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

July 27, 2024

First Submitted That Met QC Criteria

July 27, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PATHYOID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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