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
1 other identifier
interventional
144
1 country
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2025
Typical duration for phase_3
35 active sites
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
First Submitted
Initial submission to the registry
February 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 6, 2025
CompletedStudy Start
First participant enrolled
April 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
December 31, 2025
December 1, 2024
1.7 years
February 24, 2025
December 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression - Free Survival (PFS) evaluated by the Independent Review Committee (IRC)
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 Outcomes (6)
Overall Survival (OS)
34 months
Compare the Progression - Free Survival (PFS) evaluated by the researchers in the treatment group and the placebo group
34 months
Compare the objective response rate (ORR) between the treatment group and the placebo group
34 months
Compare the Disease Control Rate (DCR) between the treatment group and the placebo group
34 months
Compare the Duration of Response (DOR) between the treatment group and the placebo group
34 months
- +1 more secondary outcomes
Study Arms (2)
AL2846 Capsules
EXPERIMENTALThe treatment cycle of AL2846 Capsules is 28 days.
AL2846 Placebo
PLACEBO COMPARATORThe treatment cycle of AL2846 Placebo is 28 days.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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:
- Lesions show no iodine uptake on post-Iodine-131 therapy whole-body scan and are unlikely to benefit from further Iodine-131 therapy.
- Previously iodine-avid lesions progressively lose iodine uptake after Iodine-131 therapy.
- Mixed iodine-avid and non-iodine-avid lesions in the same patient with no biochemical response.
- Iodine-avid lesions with disease progression (radiologically confirmed) within 12 months.
- 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:
- +9 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
The Second Hospital Of Anhui Medical University
Hefei, Anhui, 230601, China
cancer hospital Chinese academy of medical sciences
Beijing, Beijing Municipality, 100021, China
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, 400038, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Affiliated Hospital of Guilin Medical University
Gui'lin, Guangxi, 541001, China
The Second Affiliated Hospital Of GXUST
Liuchow, Guangxi, 545006, China
The First Affiliated Hospital of Hainan Medical University
Hainan, Haikou, 570102, China
CangZhou Center Hospital
Cangzhou, Hebei, 61012, China
Harbin Medical University cancer hospital
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
The Affiliated Hospital of XuZhou Medical University
Xuzhou, Jiangsu, 21002, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
JIANGXI cancer hospital
Nanchang, Jiangxi, 330029, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130000, China
JILIN cancer hospital
Changchun, Jilin, 130000, China
Liaoning Cancer Hospital
Shengyang, Liaoning, 110000, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaani, 710000, China
Xijing Hospital
Xi'an, Shaanxi, 710032, China
Shaanxi Provincial People'S Hospital
Xi'an, Shaanxi, 710068, China
The Second Hospital of Shandong University
Jinan, Shandong, 250033, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Weifang people's Hospital
Weifang, Shandong, 261000, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200030, China
Shanghai Jiaotong University School of Medicine, Tongji Hospital
Shanghai, Shanghai Municipality, 200120, China
West China Hospital of Si chuan University
Chengdu, Sichuan, 610000, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300070, China
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, 300202, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 841100, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2025
First Posted
March 6, 2025
Study Start
April 18, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
December 31, 2025
Record last verified: 2024-12