NCT06848920Not yet recruitingPhase 2
Study of Sinibolimab Combined with Lenvatinib As Neoadjuvant Therapy for Locally Advanced Unresectable Differentiated Thyroid Carcinoma
Phase II Clinical Study of Sinibolimab Combined with Lenvatinib As Neoadjuvant Therapy for Locally Advanced Unresectable Differentiated Thyroid Carcinoma
Source: ClinicalTrials.gov · Last updated 27 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is a single-arm, prospective investigation aimed at evaluating the efficacy of Sinibolimab combined with Lenvatinib as neoadjuvant therapy for locally advanced unresectable differentiated thyroid carcinoma in a Phase II clinical trial. The study plans to enroll 20 patients with locally advanced unresectable papillary thyroid carcinoma. Eligible participants will receive a combination of Sinibolimab and Lenvatinib for four cycles. After completing the four cycles of treatment, the tumor response will be assessed to determine the feasibility of surgical intervention. Participants who complete treatment will enter a follow-up period for safety monitoring and survival assessment. The primary endpoints of the study include the major pathological response (MPR) and the R0/R1 resection rate. Secondary endpoints include the objective response rate (ORR) after four cycles, 1-year and 2-year disease-free survival (DFS) rates, serious adverse events (SAE), and immune-related adverse events (irAE).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 26 Jan 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Zhejiang University
- Diseases
- Thyroid cancer
- NCT number
- NCT06848920
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 1 Mar 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.