Actively Recruiting
A Randomized, Double-Blind, Multicenter Phase III Trial Evaluating AL2846 Capsules Versus Placebo in Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma After Prior VEGFR-Targeted Therapy
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2025-12-31
144
Participants Needed
35
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Age between 18 and less than 75 years at consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Anticipated survival of more than 12 weeks.
- At least one measurable lesion as defined by RECIST 1.1 criteria.
- Disease progression after receiving no more than 2 lines (and no more than 3 types) of VEGFR tyrosine kinase inhibitor therapy.
- Confirmed iodine-refractory status by one or more specified criteria related to iodine uptake and response.
- Thyroid stimulating hormone (TSH) level of 0.5 mIU/L or lower under TSH-suppressive therapy.
- Laboratory parameters meeting specific minimum levels for hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, creatinine clearance, coagulation times, and serum albumin.
- For participants of childbearing potential: Agreement to use effective contraception during the study and for 6 months after; females must have a negative pregnancy test within 7 days before enrollment.
You will not qualify if you...
- Patients with undifferentiated thyroid carcinoma or medullary thyroid carcinoma.
- Patients with other malignancies except those treated with surgery with disease-free survival of 5 years, cured cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder tumors.
- Individuals with conditions affecting oral medication use, such as swallowing difficulties, chronic diarrhea, or intestinal obstruction.
- Unresolved adverse reactions from previous treatments greater than CTCAE grade 1, except certain specified toxicities.
- Known allergy to components of the study drug.
- Participation in other anti-tumor drug clinical trials within 4 weeks before randomization.
- Any condition judged by the investigator to seriously endanger safety or study completion.
Research Team
F
Feng Shi, Master
X
Xiangqian Zheng, Doctor
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