Phase 3 Trial of AL2846 Capsules Versus Placebo for Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer After VEGFR-Targeted Therapy

What this Trial Is About

Researchers are evaluating AL2846, a multi-target tyrosine kinase inhibitor, in adults with locally advanced or metastatic differentiated thyroid cancer that no longer responds to iodine treatment and has progressed after previous VEGFR-targeted therapies. This Phase III trial aims to see if AL2846 can extend the time patients live without their cancer worsening compared with a placebo. The study is led by Chia Tai Tianqing Pharmaceutical Group and involves random assignment to treatment groups with both patients and investigators unaware of the assignments. Participants will receive either AL2846 capsules or a placebo in 28-day treatment cycles. The AL2846 drug targets specific receptors involved in tumor growth, including c-MET, c-KIT, VEGFR1, and RET. The study will last up to 34 months, during which patients will be monitored for disease progression, response rates, survival, and safety. Both groups follow the same cycle length to compare outcomes fairly. Throughout the trial, participants will undergo regular assessments including imaging scans to measure tumor size, blood tests to monitor health status and safety, and evaluations by an independent review committee and researchers. Researchers will track progression-free survival as the main outcome, along with overall survival, response rates, and duration of response. Safety of AL2846 compared to placebo will also be closely monitored. Participants involvement may last up to nearly three years, allowing for detailed observation of treatment effects and tolerability.

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