New hope for stubborn thyroid cancer: experimental drug aims to slow tumor growth
NCT ID NCT06860971
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the experimental drug AL2846 can slow cancer growth in people with advanced thyroid cancer that no longer responds to radioiodine or previous targeted therapy. About 144 participants will receive either AL2846 or a placebo. The main goal is to see how long people live without their cancer getting worse.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 144 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
35 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Hospital of Guilin Medical University
NOT_YET_RECRUITINGGui'lin, Guangxi, 541001, China
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Affiliated Tumor Hospital of Xinjiang Medical University
NOT_YET_RECRUITINGÜrümqi, Xinjiang, 841100, China
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CangZhou Center Hospital
NOT_YET_RECRUITINGCangzhou, Hebei, 61012, China
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China-Japan Union Hospital of Jilin University
NOT_YET_RECRUITINGChangchun, Jilin, 130000, China
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Fujian Medical University Union Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, 350001, China
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Gansu Provincial Cancer Hospital
NOT_YET_RECRUITINGLanzhou, Gansu, 730050, China
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Harbin Medical University cancer hospital
NOT_YET_RECRUITINGHarbin, Heilongjiang, 150081, China
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Henan Cancer Hospital
NOT_YET_RECRUITINGZhengzhou, Henan, 450000, China
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Hunan Cancer Hospital
NOT_YET_RECRUITINGChangsha, Hunan, 410000, China
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JIANGXI cancer hospital
NOT_YET_RECRUITINGNanchang, Jiangxi, 330029, China
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JILIN cancer hospital
NOT_YET_RECRUITINGChangchun, Jilin, 130000, China
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Liaoning Cancer Hospital
NOT_YET_RECRUITINGShengyang, Liaoning, 110000, China
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Nanjing First Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210006, China
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Shaanxi Provincial People'S Hospital
NOT_YET_RECRUITINGXi'an, Shaanxi, 710068, China
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Shandong Cancer Hospital
NOT_YET_RECRUITINGJinan, Shandong, 250117, China
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Shanghai Jiaotong University School of Medicine, Tongji Hospital
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200120, China
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Shanghai Sixth People's Hospital
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200030, China
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Sun Yat-sen University Cancer Center
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510060, China
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The Affiliated Hospital of XuZhou Medical University
NOT_YET_RECRUITINGXuzhou, Jiangsu, 21002, China
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The First Affiliated Hospital of Hainan Medical University
NOT_YET_RECRUITINGHainan, Haikou, 570102, China
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The First Affiliated Hospital of Xi'an Jiao Tong University
NOT_YET_RECRUITINGXi'an, Shaani, 710000, China
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The Second Affiliated Hospital Of GXUST
NOT_YET_RECRUITINGLiuzhou, Guangxi, 545006, China
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The Second Affiliated Hospital of Nanchang University
NOT_YET_RECRUITINGNanchang, Jiangxi, 330006, China
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The Second Hospital Of Anhui Medical University
NOT_YET_RECRUITINGHefei, Anhui, 230601, China
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The Second Hospital of Shandong University
NOT_YET_RECRUITINGJinan, Shandong, 250033, China
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The Southwest Hospital of Amu
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, 400038, China
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Tianjin Cancer Hospital Airport Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300070, China
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Tianjin Medical University Cancer Institute&Hospital
RECRUITINGTianjin, Tianjin Municipality, 300202, China
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, 430000, China
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Weifang people's Hospital
NOT_YET_RECRUITINGWeifang, Shandong, 261000, China
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West China Hospital of Si chuan University
NOT_YET_RECRUITINGChengdu, Sichuan, 610000, China
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Xijing Hospital
NOT_YET_RECRUITINGXi'an, Shaanxi, 710032, China
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Yunnan Cancer Hospital
NOT_YET_RECRUITINGKunming, Yunnan, 650118, China
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Zhejiang Cancer Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310005, China
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cancer hospital Chinese academy of medical sciences
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Light-Based probe aims to spot thyroid cancer faster
- Mapping how thyroid tumors spread and what surgery leaves behind
- Can a video keep thyroid cancer patients on track after surgery?
- Can doctors safely watch small thyroid cancers instead of removing them?
- Can heat replace the scalpel for small thyroid tumors?
- Thyroid surgery under the microscope: what 3,000 real operations reveal