Actively Recruiting
A Randomized, Double-Blind, Multicenter Phase III Trial Evaluating AL2846 Capsules Versus Placebo in Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma After Prior VEGFR-Targeted Therapy
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2025-12-31
144
Participants Needed
35
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AL2846, a multi-target tyrosine kinase inhibitor, in adults with locally advanced or metastatic differentiated thyroid cancer that no longer responds to iodine treatment and has progressed after previous VEGFR-targeted therapies. This Phase III trial aims to see if AL2846 can extend the time patients live without their cancer worsening compared with a placebo. The study is led by Chia Tai Tianqing Pharmaceutical Group and involves random assignment to treatment groups with both patients and investigators unaware of the assignments. Participants will receive either AL2846 capsules or a placebo in 28-day treatment cycles. The AL2846 drug targets specific receptors involved in tumor growth, including c-MET, c-KIT, VEGFR1, and RET. The study will last up to 34 months, during which patients will be monitored for disease progression, response rates, survival, and safety. Both groups follow the same cycle length to compare outcomes fairly. Throughout the trial, participants will undergo regular assessments including imaging scans to measure tumor size, blood tests to monitor health status and safety, and evaluations by an independent review committee and researchers. Researchers will track progression-free survival as the main outcome, along with overall survival, response rates, and duration of response. Safety of AL2846 compared to placebo will also be closely monitored. Participants' involvement may last up to nearly three years, allowing for detailed observation of treatment effects and tolerability.
CONDITIONS
Brief 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 the informed consent form, and demonstrate 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 of 0 or 1.
- Anticipated survival of more than 12 weeks.
- At least one measurable lesion as defined by RECIST 1.1 criteria.
- Disease progression after receiving no more than 2 lines (and no more than 3 types) of VEGFR tyrosine kinase inhibitor therapy.
- Confirmed iodine-refractory status by one or more specified criteria related to iodine uptake and response.
- Thyroid stimulating hormone (TSH) level of 0.5 mIU/L or lower under TSH-suppressive therapy.
- Laboratory parameters meeting specific minimum levels 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 the study and for 6 months after; females must have a negative pregnancy test within 7 days before enrollment.
You will not qualify if you...
- Patients with undifferentiated thyroid carcinoma or medullary thyroid carcinoma.
- Patients with other malignancies except those treated with surgery with disease-free survival of 5 years, cured cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder tumors.
- Individuals with conditions affecting oral medication use, such as swallowing difficulties, chronic diarrhea, or intestinal obstruction.
- Unresolved adverse reactions from previous treatments greater than CTCAE grade 1, except certain specified toxicities.
- Known allergy to components of the study drug.
- Participation in other anti-tumor drug clinical trials within 4 weeks before randomization.
- Any condition judged by the investigator to seriously endanger safety or study completion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 34 months
Participants receive either AL2846 Capsules or placebo in 28-day treatment cycles to evaluate their effect on advanced radioiodine-refractory differentiated thyroid carcinoma after prior VEGFR-targeted therapy.
Visits occur every 28 days for treatment cycles
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
X
Xiangqian Zheng, Doctor
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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