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NCT Number: NCT06530316

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

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.

Recruiting

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Key information

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan Univeristy Shanghai Cancer Center

Shanghai, China

Location status: Recruiting

Location contact

Yu Wang, M.D.

CONTACT

[email protected]

86-021-64175590 ext. 65805

Who can participate

Only the study team can determine whether someone qualifies for participation.

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:
  • Local advanced thyroid cancer with estimated surgical difficulty and inability to R0/1 resection;
  • 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;
  • 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.

Treatment and study plan

RET Inhibitor

Drug

RET inhibitors for neoadjuvant treatment

Surgery

Procedure

Operable patients receive surgery after neoadjuvant therapy

Primary outcomes

  1. R0/1 resection rate

    Time frame: 1 year

Secondary outcomes

  1. Objective Response Rate, ORR

    Time frame: 1 year

  2. Disease Control Rate,DCR

    Time frame: 1 year

  3. Time to objective response,TTR

    Time frame: 1 year

  4. Progression Free Survival,PFS

    Time frame: 5 years

  5. Overall Survival,OS

    Time frame: 5 years

  6. Adverse Events

    Time frame: During RET inhibitor treatment, up to 5 years

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Jul 31, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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