PD-1 Inhibitor Plus Anti-EGFR Therapy And Radiotherapy in Locally Advanced NPC Resistant to Induction Chemotherapy

Last updated: November 26, 2023
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Nasopharyngeal Cancer

Treatment

Anti-EGFR and PD-1 inhibitor arm

Clinical Study ID

NCT06156878
2022007
  • Ages 18-75
  • All Genders

Study Summary

Because nasopharyngeal carcinoma (NPC)is very sensitive to radiation and the specificity of the anatomical structure, radiotherapy has become the core treatment for NPC. Although induction chemotherapy combined with cisplatin-based concurrent chemoradiotherapy can effectively improve the overall survival and progression-free survival of NPC, such a sequential pattern can further exacerbate the toxic side effects of treatment, such as mucosal reactions and gastrointestinal toxicity. Therefore, it is particularly important to explore another treatment mode with high efficiency and low toxicity. Secondly, patients with poor response after induction chemotherapy indicate chemotherapy resistance. Whether patients can still benefit from concurrent platinum-based chemotherapy in the followed radiotherapy is doubtful. PD-1 inhibitor and anti-EGFR monoclonal antibody have proved to improve outcomes of head and neck cancers including EBV-related NPC, which have also showed relatively low toxicity. In this study, radiotherapy combined with PD-1 inhibitor and anti-EGFR monoclonal antibody were applied to treat patients with locally advanced NPC who were resistant to induction chemotherapy.

Eligibility Criteria

Inclusion

Inclusion Criteria: Histologically confirmed locally advanced NPC; IHC EGFR positive; Eastern CooperativeOncology Group (ECOG) performance status of 0 or 1; Imaging assessment of MR afterinduction chemotherapy revealed the responses to induction chemotherapy are less than 50%Partial Response(PR) or EBVDNA copy number decreased by less than 50%; No prior anti-tumortreatment; Normal complete blood count; Normal hepatic function; Normal renal function (creatinine ≤ 1.5 times the upper limit of normal). -

Exclusion

Exclusion Criteria: Previous radiotherapy; A history of any other type of malignancy; Pregnancy or lactation;Allergy to anti-EGFR monoclonal antibody; IHC EGFR negative; Allergy to PD-1 inhibitor;Obvious disfunction of liver, renal, cardiac or lung function; Un controlled infection;Systemic metastasis or distant metastasis; Patients with severe gastrointestinal diseases;Patients with mental disorders affecting patient participation in trial judgement; Cannottake contrast-MRI imaging.

Study Design

Total Participants: 41
Treatment Group(s): 1
Primary Treatment: Anti-EGFR and PD-1 inhibitor arm
Phase: 2
Study Start date:
August 01, 2022
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Eye & ENT Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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