RecruitingPhase 2NCT06787911

Donafenib Combined With Anti-PD-1 Antibody for Neoadjuvant Therapy in Locally Advanced Thyroid Cancer

The Efficacy and Safety of Donafenib Combined With Anti-PD-1 Antibody for Neoadjuvant Therapy in Locally Advanced Thyroid Cancer: a Phase II Study


Sponsor

Yu Wang

Enrollment

14 participants

Start Date

Jul 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-arm intervention study. Locally advanced differentiated thyroid carcinoma patients receive neoadjuvant therapy with Donafenib and PD-1 antibody Sintilimab and those who can undergo surgery after neoadjuvant therapy receive surgical treatment. The aim of the study is to evaluate the efficacy and safety of Donafenib combined with PD-1 antibody in neoadjuvant therapy of locally advanced thyroid cancer.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — donafenib (a targeted therapy) and an anti-PD-1 immunotherapy drug — given before surgery to shrink locally advanced thyroid cancer that cannot be easily removed with an operation. The goal is to see if this treatment can make the cancer small enough to be fully removed. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with locally advanced differentiated thyroid cancer (a type that originates from normal thyroid cells) confirmed by a tissue test - Your cancer is considered hard to remove completely with surgery, or has invaded nearby structures like the windpipe, esophagus, or major blood vessels - You have not received any cancer treatment before - You are reasonably fit (ECOG score 0-2) and your organs are functioning adequately - You are willing to have a biopsy at the start and end of the study **You may NOT be eligible if...** - Your thyroid cancer is an undifferentiated (anaplastic), medullary, lymphoma, or sarcoma type - You have cancer spread to the brain or lining of the brain - You have active autoimmune disease or have previously taken immune checkpoint drugs (anti-PD-1, anti-CTLA-4) - You have had major surgery within the past 4 weeks - You have serious heart conditions, active infections (HIV, hepatitis B/C, tuberculosis), or uncontrolled bleeding - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDonafeib with Sintilimab

Patients receive Donafenib and PD-1 antibody Sintilimab


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT06787911


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