RecruitingPhase 2NCT05260671

Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN

An Exploratory Clinical Study to Evaluate the Efficacy and Safety of Penpulimab in Combination With Cetuximab as First-line Treatment in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/MSCCHN)


Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

48 participants

Start Date

Jan 25, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a multicenter, prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of Penpulimab injection combined with cetuximab in the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — penpulimab (an immunotherapy) and cetuximab (a targeted therapy) — as a first-line treatment for people with head and neck cancer that has come back or spread to other parts of the body and cannot be treated with surgery or radiation. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with squamous cell carcinoma of the head and neck (mouth, throat, voice box, or lower throat region) - Your cancer has returned or spread and cannot be treated with surgery or radiation - Your tumor tests positive for PD-L1 (a marker your doctor can check) - You have at least one measurable tumor - You are in good physical condition (ECOG 0 or 1) and expected to live at least 3 more months **You may NOT be eligible if...** - You have received prior systemic treatment for recurrent or metastatic disease - You have serious heart, liver, or blood count 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

DRUGPenpulimab combined with cetuximab

PD-1 antibody combined with EGFR inhibitors, biweekly


Locations(2)

Department of radiotherapy,The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Department of Radiotherapy, Eye & ENT Hospital of Fudan University

Shanghai, China

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NCT05260671


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