NCT06156878

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

Radiotherapy Combined With PD-1 Inhibitor and Anti-EGFR Monoclonal Antibody for Locally Advanced Nasopharyngeal Carcinoma Resistant to Induction Chemotherapy: A Prospective Phase II Study
Fudan University·Phase 2·ClinicalTrials.gov·combination productRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Nasopharyngeal Carcinoma
Drug/Device/Intervention
Anti-EGFR and PD-1 inhibitor arm
Study type
Interventional
Intervention type
combination product
Sponsor & location
Primary sponsor
Fudan University
Location
Shanghai, China
Timeline & enrollment
Phase
Phase 2
Start date
Aug 01, 2022
End date
Aug 01, 2025
Enrollment
41 participants
Primary outcome

PFS,OS

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.

ICD-10 classifications
Malignant neoplasm of nasopharynxMalignant neoplasm: Nasopharynx, unspecifiedMalignant neoplasm: Overlapping lesion of nasopharynxBenign neoplasm: NasopharynxMalignant neoplasm: Posterior wall of nasopharynx
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06156878
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06156878 through Pure Global AI's free database. This Phase 2 trial is sponsored by Fudan University and is currently Recruiting. The study focuses on Nasopharyngeal Carcinoma. Target enrollment is 41 participants.

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