Actively Recruiting
A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2025-12-31
144
Participants Needed
35
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants voluntarily join the study, sign informed consent, and show good compliance
- Histologically or cytologically confirmed locally advanced or metastatic differentiated thyroid carcinoma
- Age between 18 and less than 75 years at consent
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected survival longer than 12 weeks
- At least one measurable tumor lesion per RECIST 1.1 criteria
- Disease progression after no more than 2 lines (up to 3 types) of VEGFR tyrosine kinase inhibitor therapy
- Confirmed iodine-refractory status by one or more specific criteria including lack of iodine uptake or disease progression after Iodine-131 therapy
- Thyroid stimulating hormone (TSH) level ≤ 0.5 mIU/L during TSH-suppressive treatment
- Laboratory values meeting minimum requirements for hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, creatinine clearance, coagulation times, and serum albumin
- For participants of childbearing potential, agreement to use effective contraception during and for 6 months after the study; females must have a negative pregnancy test within 7 days before enrollment
You will not qualify if you...
- Presence of undifferentiated thyroid carcinoma or medullary thyroid carcinoma
- History or current diagnosis of other malignancies, except certain treated cancers with disease-free survival of 5 years or specific non-invasive tumors
- Conditions affecting oral medication intake such as swallowing difficulties or chronic diarrhea
- Unresolved adverse reactions from prior treatments above grade 1 severity (with specified exceptions)
- Known allergy to components of the study drug
- Participation in other anti-cancer drug trials within 4 weeks prior to randomization
- Any condition judged by the investigator to seriously endanger participant safety or interfere with study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
The Second Hospital Of Anhui Medical University
Hefei, Anhui, China, 230601
Not Yet Recruiting
2
cancer hospital Chinese academy of medical sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
3
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, China, 400038
Not Yet Recruiting
4
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Not Yet Recruiting
5
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
6
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
7
Affiliated Hospital of Guilin Medical University
Gui'lin, Guangxi, China, 541001
Not Yet Recruiting
8
The Second Affiliated Hospital Of GXUST
Liuzhou, Guangxi, China, 545006
Not Yet Recruiting
9
The First Affiliated Hospital of Hainan Medical University
Hainan, Haikou, China, 570102
Not Yet Recruiting
10
CangZhou Center Hospital
Cangzhou, Hebei, China, 61012
Not Yet Recruiting
11
Harbin Medical University cancer hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
12
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
13
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Not Yet Recruiting
14
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
15
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Not Yet Recruiting
16
The Affiliated Hospital of XuZhou Medical University
Xuzhou, Jiangsu, China, 21002
Not Yet Recruiting
17
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
18
JIANGXI cancer hospital
Nanchang, Jiangxi, China, 330029
Not Yet Recruiting
19
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China, 130000
Not Yet Recruiting
20
JILIN cancer hospital
Changchun, Jilin, China, 130000
Not Yet Recruiting
21
Liaoning Cancer Hospital
Shengyang, Liaoning, China, 110000
Not Yet Recruiting
22
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaani, China, 710000
Not Yet Recruiting
23
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Not Yet Recruiting
24
Shaanxi Provincial People'S Hospital
Xi'an, Shaanxi, China, 710068
Not Yet Recruiting
25
The Second Hospital of Shandong University
Jinan, Shandong, China, 250033
Not Yet Recruiting
26
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
27
Weifang people's Hospital
Weifang, Shandong, China, 261000
Not Yet Recruiting
28
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200030
Not Yet Recruiting
29
Shanghai Jiaotong University School of Medicine, Tongji Hospital
Shanghai, Shanghai Municipality, China, 200120
Not Yet Recruiting
30
West China Hospital of Si chuan University
Chengdu, Sichuan, China, 610000
Not Yet Recruiting
31
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300070
Not Yet Recruiting
32
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, China, 300202
Actively Recruiting
33
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 841100
Not Yet Recruiting
34
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Not Yet Recruiting
35
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Not Yet Recruiting
Research Team
F
Feng Shi, Master
CONTACT
X
Xiangqian Zheng, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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