NCT06195228

Brief Summary

This is a retrospective and prospective real-world clinical study of molecular typing in the treatment of advanced thyroid cancer. The retrospective study : Patients with advanced thyroid cancer who received precise treatment in the 24 participated hospitals from January 2020 to December 2023 were retrieved. The number of previous treatment lines was not limited. Patients who met the inclusion criteria were screened according to the inclusion and exclusion criteria. Demographic information, clinical characteristics, tumor treatment history, medication regimen, adverse reactions, molecular test results, survival follow-up results and other data were collected. The prospective study : Patients with advanced thyroid cancer who received precise treatment in the 24 Chinese hospitals from January 2024 to April 2027 were enrolled.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_4

Timeline
33mo left

Started Jan 2020

Longer than P75 for phase_4

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Jan 2020Dec 2028

Study Start

First participant enrolled

January 1, 2020

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

7 years

First QC Date

December 23, 2023

Last Update Submit

August 9, 2025

Conditions

Advanced Thyroid Cancer Patients Who Received Target Therapy

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate(ORR)

    Complete remission rate+ partial remission rate

    up to approximately 3 years

Secondary Outcomes (5)

  • Duration of Response(DOR)

    up to approximately 3 years

  • Disease Control Rate(DCR)

    up to approximately 3 years

  • Time to response(TTR)

    up to approximately 3 years

  • Progression Free Survival(PFS)

    up to approximately 3 years

  • Overall survival(OS)

    up to approximately 3 years

Study Arms (5)

Radioiodine-refractory differentiated thyroid cancer

EXPERIMENTAL

advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment

Drug: dabrafenib plus trametinib with or without PD-1 antibodyDrug: entrectinib or larotrectinib with or without anti-PD-1 antibdoyDrug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoyDrug: anlotinib or anlotinib plus anti-PD-1 antibodyDrug: lenvatinib plus anti-PD-1 antibodyDrug: Other Targets: precise treatment based on the target

Differentiated thyroid carcinoma not suitable for radioiodine therapy

EXPERIMENTAL

advanced or metastatic differentiated thyroid cancer patients who are not suitable for radio iodine therapy, for example, DTC patients with huge neck tumor but cannot receive the thyroid ectomy

Drug: dabrafenib plus trametinib with or without PD-1 antibodyDrug: entrectinib or larotrectinib with or without anti-PD-1 antibdoyDrug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoyDrug: anlotinib or anlotinib plus anti-PD-1 antibodyDrug: lenvatinib plus anti-PD-1 antibodyDrug: Other Targets: precise treatment based on the target

Medullary thyroid cancer

EXPERIMENTAL

patients with advanced or metastatic medullary thyroid cancer

Drug: dabrafenib plus trametinib with or without PD-1 antibodyDrug: entrectinib or larotrectinib with or without anti-PD-1 antibdoyDrug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoyDrug: anlotinib or anlotinib plus anti-PD-1 antibodyDrug: lenvatinib plus anti-PD-1 antibodyDrug: Other Targets: precise treatment based on the target

High-grade or poorly differentiated thyroid cancer

EXPERIMENTAL

patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer

Drug: dabrafenib plus trametinib with or without PD-1 antibodyDrug: entrectinib or larotrectinib with or without anti-PD-1 antibdoyDrug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoyDrug: anlotinib or anlotinib plus anti-PD-1 antibodyDrug: lenvatinib plus anti-PD-1 antibodyDrug: Other Targets: precise treatment based on the target

Anaplastic thyroid cancer

EXPERIMENTAL

patients with anaplastic thyroid cancer

Drug: dabrafenib plus trametinib with or without PD-1 antibodyDrug: entrectinib or larotrectinib with or without anti-PD-1 antibdoyDrug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoyDrug: anlotinib or anlotinib plus anti-PD-1 antibodyDrug: lenvatinib plus anti-PD-1 antibodyDrug: Other Targets: precise treatment based on the target

Interventions

dabrafenib plus trametinib with or without PD-1 antibodyDRUG

advanced thyroid cancer patients who harbor BRAF V600E mutation

Anaplastic thyroid cancerDifferentiated thyroid carcinoma not suitable for radioiodine therapyHigh-grade or poorly differentiated thyroid cancerMedullary thyroid cancerRadioiodine-refractory differentiated thyroid cancer
entrectinib or larotrectinib with or without anti-PD-1 antibdoyDRUG

advanced thyroid cancer patients who harbor NTRK mutation

Anaplastic thyroid cancerDifferentiated thyroid carcinoma not suitable for radioiodine therapyHigh-grade or poorly differentiated thyroid cancerMedullary thyroid cancerRadioiodine-refractory differentiated thyroid cancer
pralsetinib or selpercatinib with or without anti-PD-1 antibdoyDRUG

advanced thyroid cancer patients who harbor RET fusion or medullary thyroid carcinoma patients who habor RET mutation.

Anaplastic thyroid cancerDifferentiated thyroid carcinoma not suitable for radioiodine therapyHigh-grade or poorly differentiated thyroid cancerMedullary thyroid cancerRadioiodine-refractory differentiated thyroid cancer
anlotinib or anlotinib plus anti-PD-1 antibodyDRUG

For patients with medullary carcinoma, if there is no RET gene mutation or RET gene mutation is unknown

Anaplastic thyroid cancerDifferentiated thyroid carcinoma not suitable for radioiodine therapyHigh-grade or poorly differentiated thyroid cancerMedullary thyroid cancerRadioiodine-refractory differentiated thyroid cancer
lenvatinib plus anti-PD-1 antibodyDRUG

Advanced thyroid cancer patients who don't harbor the above gene mutation or could not afford the cost of precision treatment even with the above gene mutation

Anaplastic thyroid cancerDifferentiated thyroid carcinoma not suitable for radioiodine therapyHigh-grade or poorly differentiated thyroid cancerMedullary thyroid cancerRadioiodine-refractory differentiated thyroid cancer
Other Targets: precise treatment based on the targetDRUG

Advanced thyroid cancer patients who had other treatment targets not included above

Anaplastic thyroid cancerDifferentiated thyroid carcinoma not suitable for radioiodine therapyHigh-grade or poorly differentiated thyroid cancerMedullary thyroid cancerRadioiodine-refractory differentiated thyroid cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients volunteered to participate in this study and signed informed consent;
  • Each center can be enrolled in patients who meet the age of their own practice range, regardless of gender ;
  • Histologically diagnosed locally advanced or recurrent / metastatic thyroid cancer that cannot undergo radical surgery meets one of the following requirements:
  • Radioiodine-refractory differentiated thyroid cancer (RAIR-DTC);
  • Differentiated thyroid carcinoma not suitable for iodine therapy;
  • Medullary thyroid carcinoma (MTC);
  • poorly differentiated thyroid cancer (PDTC) or anaplastic thyroid cancer (ATC);
  • Thyroid-related pathogenic or therapeutic target gene detection was performed before enrollment.

You may not qualify if:

  • Patients who are participating in clinical trials of other drugs;
  • There is evidence that the patients are pregnant or lactating;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Caixia Liu

Hohhot, Inner Mongolia, 010000, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanxi Cancer Hospital

Shanxi, Taiyuan, 030000, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

Peking union medical college hospital

Beijing, 100000, China

RECRUITING

MeSH Terms

Interventions

dabrafenibtrametinibentrectiniblarotrectinibpralsetinibselpercatinibanlotiniblenvatinib

Study Officials

  • Dongmei Ji, M.D

    Fudan University

    PRINCIPAL INVESTIGATOR

  • Yu Wang, M.D

    Fudan University

    PRINCIPAL INVESTIGATOR

  • Qinghai Ji, M.D

    Fudan University

    PRINCIPAL INVESTIGATOR

  • Yansong Lin, M.D

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongmei Ji, M.D

CONTACT

021-64175590jidongmei2000@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

December 23, 2023

First Posted

January 8, 2024

Study Start

January 1, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(8)