Study of Sinibolimab Combined with Lenvatinib As Neoadjuvant Therapy for Locally Advanced Unresectable Differentiated Thyroid Carcinoma

Launched by ZHEJIANG UNIVERSITY · Feb 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two medications, Sinibolimab and Lenvatinib, to see how effective they are as a treatment before surgery for patients with a specific type of thyroid cancer called differentiated thyroid carcinoma. The trial aims to enroll 20 adults who have locally advanced cancer that cannot be removed by surgery at the moment. Participants will receive this combined treatment for four cycles, and researchers will then evaluate how well the tumors responded to the therapy to determine if surgery can be performed safely.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of locally advanced differentiated thyroid carcinoma. They should have some measurable tumors and normal functioning of major organs. However, individuals with certain conditions, such as specific types of airway tumors or those who have undergone certain prior treatments, may not qualify. Participants can expect to be monitored closely for safety and any side effects during and after the treatment period. This study will help doctors understand the potential of this combination therapy in treating difficult-to-reach thyroid cancers and its impact on patient outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed newly diagnosed or recurrent locally advanced (T4N1M0) differentiated thyroid carcinoma with an estimated risk of R2 resection.
• • Performance Status (PS) score of 0-1. Age ≥ 18 years. Measurable lesions according to RECIST 1.1 criteria. Normal function of major organ systems.
• Exclusion Criteria:
• • Intratracheal airway tumors. Complete carotid artery encasement/invasion. Full-thickness infiltration of the esophageal wall. Arterial thrombosis/cancer thrombus. Active hemoptysis (bright red blood ≥ 1/2 teaspoon) or other uncontrolled bleeding within 21 days prior to study enrollment.
• • History of prior neck radiotherapy. Previous treatment with Lenvatinib or immunotherapy. Participants with \> 1+ proteinuria on urine dipstick will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥ 1g/24 hours will be ineligible.
• • Active, known, or suspected autoimmune diseases. Participants requiring long-term systemic corticosteroid therapy. Participants using bronchodilators, inhaled corticosteroids intermittently due to COPD or asthma, or those receiving local corticosteroid injections may be eligible.
• • Active unstable angina and/or congestive heart failure. New-onset myocardial infarction within the last 6 months.