RecruitingPhase 2NCT06494995

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


Sponsor

Fudan University

Enrollment

52 participants

Start Date

Jul 3, 2024

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether combining an immunotherapy drug (AK104, a dual PD-1/CTLA-4 blocker) with low-dose targeted radiation can help people with recurrent or metastatic head and neck cancer or nasopharyngeal cancer after their first-line treatment has stopped working. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with recurrent or metastatic head and neck squamous cell carcinoma or nasopharyngeal carcinoma - Your cancer has progressed on first-line treatment (or relapsed within 6 months of radical radiotherapy) - You are in good physical condition (ECOG 0–1) - You have at least one measurable tumor lesion **You may NOT be eligible if...** - You have active brain metastases - You have autoimmune disease requiring systemic treatment - You have serious heart, liver, or kidney problems - 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

DRUGCadonilimab

a PD-1/CTLA-4 dual antibody

RADIATIONLow-dose radiotherapy

Low-dose radiation

RADIATIONSBRT

selected leisions to treat with stereotactic radiotherapy

DRUGCapecitabine

Capecitabine metronomic chemotherapy


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06494995


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