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NCT06860971

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

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-18

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AL2846 Capsules

The treatment cycle of AL2846 Capsules is 28 days.

Group Type EXPERIMENTAL

AL2846 Capsules

Intervention Type DRUG

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 Placebo

The treatment cycle of AL2846 Placebo is 28 days.

Group Type PLACEBO_COMPARATOR

AL2846 Placebo

Intervention Type DRUG

AL2846 Placebo without drug substance.

Interventions

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AL2846 Capsules

Intervention Type DRUG

AL2846 Placebo

AL2846 Placebo without drug substance.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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