AK104 and Low-dose Radiation in Recurrent/Metastatic HNSCC After Failure of First-line Systemic Therapy
The Combination of AK104 and Low-dose Radiation Therapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma After Failure of First-line Systemic Therapy: a Phase II Study
Fudan University
52 participants
Jul 3, 2024
INTERVENTIONAL
Conditions
Summary
Currently, there is a lack of high-quality clinical evidence for subsequent treatment options for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) after first-line treatment, especially for subsequent treatment after first-line therapy combined with PD-1 inhibitors. Increasing evidence suggests that low-dose radiation (LDRT) can reshape the tumor microenvironment.Cadonilimab is a bispecific antibody that specifically binds to CTLA-4 and PD-1 proteins in the human body. Considering that low-dose radiotherapy and cadonilimab both have immunomodulatory effects, this study intends to select recurrent metastatic HNSCC patients who have failed first-line and above treatment to explore the safety and efficacy of cadonilimab combined with low-dose radiotherapy.
Eligibility
Plain Language Summary
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Interventions
a PD-1/CTLA-4 dual antibody
Low-dose radiation
selected leisions to treat with stereotactic radiotherapy
Capecitabine metronomic chemotherapy
Locations(1)
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NCT06494995