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

December 24, 2025 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • Not yet recruiting
        • The second hospital of Anhui medical university
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400038
        • Not yet recruiting
        • The Southwest Hospital of Amu
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Not yet recruiting
        • Gansu Provincial Cancer Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
    • Guangxi
      • Gui'lin, Guangxi, China, 541001
        • Not yet recruiting
        • Affiliated Hospital of Guilin Medical University
        • Contact:
      • Liuchow, Guangxi, China, 545006
        • Not yet recruiting
        • The Second Affiliated Hospital Of GXUST
        • Contact:
    • Haikou
      • Hainan, Haikou, China, 570102
        • Not yet recruiting
        • The First Affiliated Hospital of Hainan Medical University
        • Contact:
    • Hebei
      • Cangzhou, Hebei, China, 61012
        • Not yet recruiting
        • CangZhou Center Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin medical university cancer hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
      • Xuzhou, Jiangsu, China, 21002
        • Not yet recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China, 330029
    • Jilin
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • China-Japan Union Hospital of Jilin University
        • Contact:
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • Jilin Cancer Hospital
        • Contact:
    • Liaoning
      • Shengyang, Liaoning, China, 110000
        • Not yet recruiting
        • Liaoning Cancer Hospital
        • Contact:
    • Shaani
      • Xi'an, Shaani, China, 710000
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Not yet recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
      • Xi'an, Shaanxi, China, 710032
    • Shandong
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Contact:
      • Jinan, Shandong, China, 250033
        • Not yet recruiting
        • The Second Hospital of Shandong University
        • Contact:
      • Weifang, Shandong, China, 261000
        • Not yet recruiting
        • Weifang People's Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Not yet recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200120
        • Not yet recruiting
        • Shanghai Jiaotong University School of Medicine, Tongji Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Not yet recruiting
        • West China Hospital of Si chuan University
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300070
        • Not yet recruiting
        • Tianjin Cancer hospital Airport hospital
        • Contact:
      • Tianjin, Tianjin Municipality, China, 300202
        • Recruiting
        • Tianjin Medical University Cancer Institute&Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 841100
        • Not yet recruiting
        • Affiliated Tumor Hospital of Xinjiang Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650118
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310005
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
    3. Mixed iodine-avid and non-iodine-avid lesions in the same patient with no biochemical response.
    4. Iodine-avid lesions with disease progression (radiologically confirmed) within 12 months.
    5. Cumulative Iodine-131 dose ≥600 mCi (22 GBq) with no disease response (radiologically confirmed).
  • Thyroid stimulating hormone (TSH) ≤0.5 mIU/L under TSH-suppressive therapy.

  • Laboratory parameters meeting the following criteria:

    1. Hemoglobin (HGB) ≥90 g/L.
    2. Absolute neutrophil count (NEUT) ≥1.5×10⁹/L.
    3. Platelet count (PLT) ≥90×10⁹/L.
    4. Total bilirubin (TBIL) ≤1.5×ULN.
    5. Alanine aminotransferase (ALT) and Aspartate transferase (AST) ≤2.5×ULN.
    6. Creatinine clearance (CCR) ≥50 mL/min.
    7. Prothrombin time (PT), Activated partial thromboplastin time (APTT), and International Normalized Ratio (INR) ≤1.5×ULN (without anticoagulation therapy).
    8. Serum albumin (ALB) ≥30 g/L (no albumin infusion within 7 days prior to screening).
  • For participants of childbearing potential: Agreement to use effective contraception during the study and for 6 months after study completion. Females must have a negative serum/urine pregnancy test within 7 days before enrollment; males must agree to effective contraception during and for 6 months post-study.

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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AL2846 Capsules
The treatment cycle of AL2846 Capsules is 28 days.
Drug: AL2846 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).
Placebo Comparator: AL2846 Placebo
The treatment cycle of AL2846 Placebo is 28 days.
Drug: AL2846 Placebo
AL2846 Placebo without drug substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression - Free Survival (PFS) evaluated by the Independent Review Committee (IRC)
Time Frame: 34 months
Defined as the time from the date of randomization to the date of disease progression determined by IRC or death, whichever occurred firstly.
34 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 34 months
Defined as the time from the date of randomization to the date of death for any reason.
34 months
Compare the Progression - Free Survival (PFS) evaluated by the researchers in the treatment group and the placebo group
Time Frame: 34 months
PFS: The time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
34 months
Compare the objective response rate (ORR) between the treatment group and the placebo group
Time Frame: 34 months
Objective Response Rate (ORR): It is defined as the percentage of subjects with a complete response (CR) or partial response (PR) as determined by the Independent Review Committee (IRC)/investigator according to RECIST 1.1.
34 months
Compare the Disease Control Rate (DCR) between the treatment group and the placebo group
Time Frame: 34 months
Disease Control Rate (DCR): It is defined as the percentage of subjects with complete response (CR), partial response (PR), or stable disease (SD) as determined by the Independent Review Committee (IRC)/investigator according to RECIST 1.1.
34 months
Compare the Duration of Response (DOR) between the treatment group and the placebo group
Time Frame: 34 months
Duration of Response (DOR): It is defined as the time from the first documented and confirmed objective response to disease progression or death from any cause (whichever occurs first), as determined by the IRC/investigator according to RECIST v1.1.
34 months
Evaluate the safety of AL2846 capsules compared with placebo in subjects with locally advanced or metastatic iodine - refractory differentiated thyroid cancer who have failed previous VEGFR - targeted therapy
Time Frame: 34 months
The incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 grading scale.
34 months

Collaborators and Investigators

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

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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)

April 18, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 24, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL2846-III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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