RecruitingPhase 3

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

China144 participantsStarted 2025-04-18

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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).
✓. Hemoglobin (HGB) ≥90 g/L.
✓. Absolute neutrophil count (NEUT) ≥1.5×10⁹/L.
✓. Platelet count (PLT) ≥90×10⁹/L.

What they're measuring

Progression - Free Survival (PFS) evaluated by the Independent Review Committee (IRC)

Timeframe: 34 months

Trial details

NCT IDNCT06860971

SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Feng Shi, Master

0731 89762310 3192279599@qq.com

View on ClinicalTrials.gov More Thyroid Cancer trials