Treatment of advanced thyroid cancer with AL2846 capsules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of AL2846 capsules in patients with advanced or metastatic differentiated thyroid carcinoma that is resistant to iodine treatment and has not responded to previous VEGFR-targeted therapies. Participants will be randomly assigned to receive either AL2846 or a placebo, and the primary goal is to determine if AL2846 can significantly extend progression-free survival compared to the placebo. The study involves patients aged 18 to 75 with specific eligibility criteria, including confirmed iodine-refractory status and measurable disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University Cancer Institute&Hospital
  Tianjin, Tianjin Municipality, China Recruiting
• The Second Hospital Of Anhui Medical University
  Hefei, Anhui, China Not yet recruiting
• cancer hospital Chinese academy of medical sciences
  Beijing, Beijing Municipality, China Not yet recruiting
• The Southwest Hospital of Amu
  Chongqing, Chongqing Municipality, China Not yet recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Not yet recruiting
• Gansu Provincial Cancer Hospital
  Lanzhou, Gansu, China Not yet recruiting

Study contacts

• Study coordinator: Feng Shi, Master
• Email: 3192279599@qq.com
• Phone: 0731 89762310

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.