RecruitingPhase 1Phase 2NCT06802835

EGFR Antibody Combined With PD-1 Inhibitor and Chemotherapy in R/M Nasopharyngeal Carcinoma

EGFR Antibody Combined With Programmed Death-1 Inhibitor and Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Prospective, Multi-center, Phase I/II Clinical Trial


Sponsor

Sun Yat-Sen University Cancer Center

Enrollment

148 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of EGFR antibody combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of an EGFR-targeting antibody (a drug that blocks cancer cell growth signals), a PD-1 inhibitor (immunotherapy), and chemotherapy in patients with nasopharyngeal carcinoma (a cancer of the back of the nose and throat) that has come back or spread. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed nasopharyngeal carcinoma that has recurred or spread - You have not yet received any treatment for the recurrence or metastasis - Your general health is good (ECOG 0–1) - You have adequate blood, liver, and kidney function **You may NOT be eligible if...** - You have previously received chemotherapy, immunotherapy, or radiation for the recurrent/metastatic disease - You have active autoimmune disease - You have uncontrolled heart disease - 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

DRUGEGFR Antibody

6 cycles for combined therapy. Maintenance for 1 year.

DRUGPD-1 antibody

6 cycles for combined therapy. Maintenance for 1 year.

DRUGGemcitabine, Cisplatin

6 cycles for combined therapy.

RADIATIONIMRT

IMRT for primary lesion


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06802835


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