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PD-1 Inhibitor Plus Anti-EGFR Therapy And Radiotherapy in Locally Advanced NPC Resistant to Induction Chemotherapy - Trial NCT06156878

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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NCT06156878
Phase 2
Recruiting
combination product
Trial Details
ClinicalTrials.gov โ€ข NCT06156878
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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

Study Focus

Nasopharyngeal Carcinoma

Anti-EGFR and PD-1 inhibitor arm

Interventional

combination product

Sponsor & Location

Fudan University

Shanghai, China

Timeline & Enrollment

Phase 2

Aug 01, 2022

Aug 01, 2025

41 participants

Primary Outcome

PFS,OS

Summary

Because nasopharyngeal carcinoma ๏ผˆNPC๏ผ‰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 nasopharynx
Malignant neoplasm: Nasopharynx, unspecified
Malignant neoplasm: Overlapping lesion of nasopharynx
Benign neoplasm: Nasopharynx
Malignant neoplasm: Posterior wall of nasopharynx

Data Source

ClinicalTrials.gov

NCT06156878

Non-Device Trial