A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Thyroid Cancer

In brief

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.

Key facts

Study ID: NCT06860971
Run by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
People needed: 144
Starts: 2025-04-18
Expected to finish: 2028-01-01
Last updated by the study team: 2025-12-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
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.

You may not qualify if…

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.

Where it is running

Tianjin Medical University Cancer Institute&Hospital — Tianjin, Tianjin Municipality, China (enrolling)
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
Liaoning Cancer Hospital — Shengyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiao Tong University — Xi'an, Shaani, China
Xijing Hospital — Xi'an, Shaanxi, China
Shaanxi Provincial People'S Hospital — Xi'an, Shaanxi, China
The Second Hospital of Shandong University — Jinan, Shandong, China

Full record on ClinicalTrials.gov

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