Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma (NCT06860971) is a Phase 3 interventional studying Thyroid Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Thyroid Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 144 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Thyroid Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants voluntarily join the study, sign the willing to sign a consent form form, and demonstrate good compliance. - diagnosed by tissue sample (biopsy-confirmed) locally advanced or metastatic differentiated thyroid carcinoma (DTC). - Age: 18 years ≤ age \<75 years (calculated based on the date of signing the willing to sign a consent form 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

AL2846 Capsules

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).

DRUG

AL2846 Placebo

AL2846 Placebo without drug substance.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
cancer hospital Chinese academy of medical sciences
Beijing, Beijing Municipality, China
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Hospital of Guilin Medical University
Gui'lin, Guangxi, China
The Second Affiliated Hospital Of GXUST
Liuzhou, Guangxi, China
The First Affiliated Hospital of Hainan Medical University
Hainan, Haikou, China
CangZhou Center Hospital
Cangzhou, Hebei, China
Harbin Medical University cancer hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of XuZhou Medical University
Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
JIANGXI cancer hospital
Nanchang, Jiangxi, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
JILIN cancer hospital
Changchun, Jilin, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06860971), the sponsor (Chia Tai Tianqing Pharmaceutical Group Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06860971 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06860971?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06860971?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06860971. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06860971. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.