RecruitingPhase 3NCT06860971

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

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

144 participants

Start Date

Apr 18, 2025

Study Type

INTERVENTIONAL

Conditions

Thyroid Cancer

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AL2846 in people with advanced thyroid cancer that no longer responds to radioiodine (radioactive iodine therapy) and has progressed after prior targeted treatments. **You may be eligible if...** - You are between 18 and 74 years old - You have locally advanced or metastatic differentiated thyroid cancer confirmed by biopsy - Your cancer no longer responds to radioiodine treatment - Your cancer progressed after 1–2 prior targeted therapy drugs (VEGFR TKI) - You are in good physical health (ECOG 0–1) with an expected survival of more than 12 weeks - You have at least one measurable tumor **You may NOT be eligible if...** - Your cancer still responds to radioiodine - You have had more than 2 lines (3 types) of targeted therapy - You are in poor general health - You are under 18 or 75 years or older Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAL2846 Capsules

AL2846 Capsule is a multi - target tyrosine kinase inhibitor, which has significant inhibitory effects on c-Mesenchymal-epithelial transition factor (c - MET), stem cell factor receptor (c - KIT), VEGFR1 and Ret Proto-Oncogene (RET).

DRUGAL2846 Placebo

AL2846 Placebo without drug substance.

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

Liuzhou, Guangxi, China

The First Affiliated Hospital of Hainan Medical University

Hainan, Haikou, China

CangZhou Center Hospital

Cangzhou, Hebei, China

Harbin Medical University cancer hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing First Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of XuZhou Medical University

Xuzhou, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

JIANGXI cancer hospital

Nanchang, Jiangxi, China

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

JILIN cancer hospital

Changchun, Jilin, China

Liaoning Cancer Hospital

Shengyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaani, China

Xijing Hospital

Xi'an, Shaanxi, China

Shaanxi Provincial People'S Hospital

Xi'an, Shaanxi, China

The Second Hospital of Shandong University

Jinan, Shandong, China

Shandong Cancer Hospital

Jinan, Shandong, China

Weifang people's Hospital

Weifang, Shandong, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Shanghai Jiaotong University School of Medicine, Tongji Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Si chuan University

Chengdu, Sichuan, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, China

Affiliated Tumor Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06860971

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