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A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma

A Randomized, Double-Blind, Multicenter Phase III Clinical Trial Evaluating AL2846 Capsule Versus Placebo in Patients With Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma Who Failed Prior VEGFR-Targeted Therapy

NCT06860971•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

This study aims to demonstrate that, in subjects with locally advanced or metastatic iodine - refractory differentiated thyroid cancer who have failed previous VEGFR - targeted therapy, AL2846 can significantly prolong progression - free survival (PFS) compared with placebo.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants voluntarily join the study, sign the informed consent form, and demonstrate good compliance.
•Histologically or cytologically confirmed locally advanced or metastatic differentiated thyroid carcinoma (DTC).
•Age: 18 years ≤ age \<75 years (calculated based on the date of signing the informed consent form).
•Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1.
•Anticipated survival \>12 weeks.
•At least one measurable lesion confirmed by RECIST 1.1 criteria.
•Disease progression (per RECIST 1.1) after receiving no more than 2 lines (no more than 3 types) lines of Vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR TKI) therapy
•Confirmed iodine-refractory status, defined by \*\*one or more\*\* of the following:
•1. Lesions show no iodine uptake on post-Iodine-131 therapy whole-body scan and are unlikely to benefit from further Iodine-131 therapy.
•2. Previously iodine-avid lesions progressively lose iodine uptake after Iodine-131 therapy.
+14 more criteria

Exclusion Criteria

•Patients with undifferentiated thyroid carcinoma or medullary thyroid carcinoma;
•Patients who have had or currently have other malignancies. The following two situations are eligible for enrollment: other malignancies treated with a single surgery and achieving a disease - free survival (DFS) of 5 consecutive years; cured cervical carcinoma in situ, non - melanoma skin cancer, and superficial bladder tumors \[Ta (non - invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\].
•Those with multiple factors affecting oral medications (such as difficulty in swallowing, chronic diarrhea, and intestinal obstruction, etc.);
•Adverse reactions from previous treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. grade score ≤ 1, except for grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non - clinically significant and asymptomatic grade 2 laboratory abnormalities, and hypothyroidism stabilized by hormone replacement therapy, and other toxicities judged by the investigator to have no safety risks.
•Known allergy to the excipient components of the study drug.
•Subjects who have participated in and used other anti - tumor clinical trial drugs within 4 weeks before randomization.
•As judged by the investigator, there are situations that seriously endanger the safety of the subject or affect the subject's completion of the study.

Locations (35)

The Second Hospital Of Anhui Medical University

Hefei, Anhui, China

cancer hospital Chinese academy of medical sciences

Beijing, Beijing Municipality, China

The Southwest Hospital of Amu

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Affiliated Hospital of Guilin Medical University

Gui'lin, Guangxi, China

The Second Affiliated Hospital Of GXUST

Liuchow, Guangxi, China

The First Affiliated Hospital of Hainan Medical University

Hainan, Haikou, China

CangZhou Center Hospital

Cangzhou, Hebei, China

Key Dates

Start Date

April 18, 2025

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2028

Last Updated

December 31, 2025

Enrollment

144

ESTIMATED participants

Conditions

Thyroid Cancer

Interventions

AL2846 Capsules

DRUG

AL2846 Placebo

DRUG

Contacts

Feng Shi, Master

CONTACT

0731 89762310 3192279599@qq.com

Xiangqian Zheng, Doctor

CONTACT

02223340123-3150 xiangqian_zheng@163.com

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

NCT06316895

Papillary Thyroid Cancer

View study

RECRUITINGPHASE2

Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)

NCT07092514

Thyroid CancerCancer of the Thyroid

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma

Inclusion Criteria

Exclusion Criteria

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

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