Thyroid CancerPhase 3NCT06860971
A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma
A Phase 3 study testing AL2846 Capsules in people with Thyroid Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 35 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- AL2846 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 35 sitesChina
- Study dates
- 18 Apr 2025to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 24Show fewer
- 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:
- Hemoglobin (HGB) ≥90 g/L.
- Absolute neutrophil count (NEUT) ≥1.5×10⁹/L.
- Platelet count (PLT) ≥90×10⁹/L.
- Total bilirubin (TBIL) ≤1.5×ULN.
- Alanine aminotransferase (ALT) and Aspartate transferase (AST) ≤2.5×ULN.
- Creatinine clearance (CCR) ≥50 mL/min.
- Prothrombin time (PT), Activated partial thromboplastin time (APTT), and International Normalized Ratio (INR) ≤1.5×ULN (without anticoagulation therapy).
- 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.
Who cannot join
- 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.
Trial locations and contacts
35 sites in 1 country. Contact the study team or a site near you to ask about taking part.
35 sites in 1 country
China35 sites, 35 recruiting
- Not yet recruiting
cancer hospital Chinese academy of medical sciences
Beijing, Beijing Municipality, 100021
Lin Gui, Doctor, guilindoctor@126.com
- Not yet recruiting
CangZhou Center Hospital
Cangzhou, Hebei, 61012
Jinhai Zou, Bachelor, zouhan1213@163.com
- Not yet recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130000
Qiang Wen, Doctor, 5301760@qq.com
- Not yet recruiting
JILIN cancer hospital
Changchun, Jilin, 130000
Nianchai Jing, Master, Jingniancai@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Feng Shi, Master, 0731-88651808, 3192279599@qq.com
- Not yet recruiting
West China Hospital of Si chuan University
Chengdu, Sichuan, 610000
Rui Huang, Doctor, huangrui1977@163.com
- Not yet recruiting
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, 400038
Yi Zhang, Doctor, zhangyi1489@sina.com
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Wenxin Zhao, Doctor, Fzhzwx888@163.com
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Shuwei Chen, Doctor, chenshuw@sysucc.org.cn
- Not yet recruiting
Affiliated Hospital of Guilin Medical University
Gui'lin, Guangxi, 541001
Wei Fu, Master, 13977385850@126.com
- Not yet recruiting
The First Affiliated Hospital of Hainan Medical University
Hainan, Haikou, 570102
Huan Xiao, Doctor, xiaohuan1164@163.com
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Linfa Li, Master, pet-ct001@163.com
- Not yet recruiting
Harbin Medical University cancer hospital
Harbin, Heilongjiang, 150081
Yali Cui, Doctor, 13351985963@126.com
- Not yet recruiting
The Second Hospital Of Anhui Medical University
Hefei, Anhui, 230601
Mingjun Zhang, Master, mjzhang2010@outlook.com
- Not yet recruiting
The Second Hospital of Shandong University
Jinan, Shandong, 250033
Wei Zhang, Doctor, sdeyzhangwei@163.com
- Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Dongyuan Zhu, Doctor, 405683898@qq.com
- Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Shiwen Zhang, Master, zhangshiwen_3@163.com
- Not yet recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050
Jun Wang, Bachelor, jack3376@126.com
- Not yet recruiting
The Second Affiliated Hospital Of GXUST
Liuzhou, Guangxi, 545006
Junming Fu, Bachelor, 404249042@qq.com
- Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Jichun Yu, Doctor, yjchns@126.com
- Not yet recruiting
JIANGXI cancer hospital
Nanchang, Jiangxi, 330029
Zhijun Chen, Master, zhijunchen361@163.com
- Not yet recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Feng Wang, Doctor, fengwangcn@hotmail.com
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200030
Qanyong Luo, Doctor, lqyn@sh163.net
- Not yet recruiting
Shanghai Jiaotong University School of Medicine, Tongji Hospital
Shanghai, Shanghai Municipality, 200120
Zhuoyin Wang, Doctor, zhuoyingwang@hotmail.com
- Not yet recruiting
Liaoning Cancer Hospital
Shengyang, Liaoning, 110000
Zhengdong Li, Bachelor, 1349946150@qq.com
- Not yet recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300070
Wenchao Zhang, Doctor, zwbeyond_999@sina.com
- Recruiting
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, 300202
Xiangqian Zheng, Doctor, xiangqian_zheng@163.com
- Not yet recruiting
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 841100
Hongtao Li, Doctor, lht4656@163.com
- Not yet recruiting
Weifang people's Hospital
Weifang, Shandong, 261000
Wenhui Wang, Master, wwh8857@163.com
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Wei Cao, Doctor, caowei@hust.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaani, 710000
Aiming Yang, Doctor, yangaimin@mail.xjtu.edu.cn
- Not yet recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Wenhui Ma, Doctor, mmwwhh1986@126.com
- Not yet recruiting
Shaanxi Provincial People'S Hospital
Xi'an, Shaanxi, 710068
Jianhui Li, Doctor, lijhmd@163.com
- Not yet recruiting
The Affiliated Hospital of XuZhou Medical University
Xuzhou, Jiangsu, 21002
Zhiyong Li, Master, lizhiyong0413@163.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Hui Yang, Bachelor, 13938276142@163.com
About this study
Official title: 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.
- Conditions
- Thyroid Cancer
- Being tested
- AL2846 Capsules, AL2846 Placebo
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL2846 CapsulesDrug
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).
AL2846 PlaceboDrug
AL2846 Placebo without drug substance.
| Study group | Role | What they receive |
|---|---|---|
| AL2846 Capsules | Experimental | The treatment cycle of AL2846 Capsules is 28 days. Receives: Drug: AL2846 Capsules |
| AL2846 Placebo | Placebo comparator | The treatment cycle of AL2846 Placebo is 28 days. Receives: Drug: AL2846 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 34 months
Secondary outcomes (6)
Overall Survival (OS)
Defined as the time from the date of randomization to the date of death for any reason.
Measured: 34 months
Compare the Progression - Free Survival (PFS) evaluated by the researchers in the treatment group and the placebo group
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.
Measured: 34 months
Compare the objective response rate (ORR) between the treatment group and the placebo group
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.
Measured: 34 months
Compare the Disease Control Rate (DCR) between the treatment group and the placebo group
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.
Measured: 34 months
Compare the Duration of Response (DOR) between the treatment group and the placebo group
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.
Measured: 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
The incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 grading scale.
Measured: 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start18 Apr 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860971
- Sponsor's protocol ID
- AL2846-III-01
- Status last verified
- Dec 2024
- First submitted
- 24 Feb 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06860971
- Acronym / sponsor ID
- AL2846-III-01
- Conditions
- Thyroid Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL2846 Capsules | Experimental | Drug: AL2846 CapsulesThe treatment cycle of AL2846 Capsules is 28 days. |
| AL2846 Placebo | Placebo comparator | Drug: AL2846 PlaceboThe treatment cycle of AL2846 Placebo is 28 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL2846 CapsulesAL2846 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). | Drug | AL2846 Capsules |
| AL2846 PlaceboAL2846 Placebo without drug substance. | Drug | AL2846 Placebo |
Primary outcome
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.
6 secondary outcomes
Overall Survival (OS)
Time frame: 34 months
Compare the Progression - Free Survival (PFS) evaluated by the researchers in the treatment group and the placebo group
Time frame: 34 months
Compare the objective response rate (ORR) between the treatment group and the placebo group
Time frame: 34 months
Compare the Disease Control Rate (DCR) between the treatment group and the placebo group
Time frame: 34 months
Compare the Duration of Response (DOR) between the treatment group and the placebo group
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AL2846 Capsules in people with Thyroid Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 35 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Shi, Master (0731 89762310, 3192279599@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression - Free Survival (PFS) evaluated by the Independent Review Committee (IRC) (time frame: 34 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.