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Compares treatment options for Thyroid Cancer
Official title A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma
ClinicalTrials.gov ID: NCT06860971
What this study is testing
What is AL2846 Capsules?
AL2846 Capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for thyroid cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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.
You likely can't join 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...
- 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 ≤...
- Known allergy to the excipient components of the study drug.
- people who have participated in and used other anti - tumor clinical trial drugs within 4 weeks before randomization.
See the full eligibility 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:
- 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...
- 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...
- 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...
- Known allergy to the excipient components of the study drug.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Gui'lin, Guangxi, China
- Liuzhou, Guangxi, China
- Hainan, Haikou, China
- Cangzhou, Hebei, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Xuzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Shengyang, Liaoning, China
- Xi'an, Shaani, China
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.