NCT04223024

Randomized Phase II Trial of Concurrent Chemoradiotherapy With or Without Nimotuzumab for High Risk Nasopharyngeal Carcinoma After Induction Chemotherapy

Active, enrolled Phase 2 Last updated 28 February 2025

What this trial tests

Phase 2 trial testing CCRT+Nimotuzumab in Nasopharyngeal Carcinoma in 246 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 January 2020

Primary endpoint
31 August 2024

1 December 2026

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	246
Start date	31 January 2020
Primary completion	31 August 2024
Estimated completion	1 December 2026
Sites	1 location across China

Drugs / interventions tested

• CCRT+Nimotuzumab — full drug profile →
• CCRT alone — full drug profile →

Conditions studied

• Nasopharyngeal Carcinoma — all drugs for Nasopharyngeal Carcinoma →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 70, any sex, with Nasopharyngeal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progress-free survival (PFS)
  Time frame: 2 years
  Defined from date of randomization to date of first documentation of progression or death due to any cause

Sponsor's own description

This is the first phase II randomized clinical trial of concurrent chemoradiotherapy with or without EGFR blocker Nimotuzumab for high risk advanced nasopharyngeal carcinoma(NPC) , determining whether concurrent chemoradiotherapy(CCRT) combined with nimotuzumab can improve the survival rate of high-risk patients and may provide new evidence for individualized comprehensive treatment of locally advanced NPC.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nasopharyngeal carcinoma: current views on the tumor microenvironment's impact on drug resistance and clinical outcomes.
   Liu H, Tang L, Li Y, Xie W, et al · · 2024 · cited 85× · PMID 38254110 · DOI 10.1186/s12943-023-01928-2
2. Precision medicine in nasopharyngeal carcinoma: comprehensive review of past, present, and future prospect.
   Siak PY, Heng WS, Teoh SSH, Lwin YY, et al · · 2023 · cited 33× · PMID 37932756 · DOI 10.1186/s12967-023-04673-8
3. Nimotuzumab, an Anti-EGFR Monoclonal Antibody, in the Treatment of Nasopharyngeal Carcinoma.
   Liang R, Yang L, Zhu X. · · 2021 · cited 30× · PMID 33504193 · DOI 10.1177/1073274821989301
4. Advance in integrating platinum-based chemotherapy with radiotherapy for locally advanced nasopharyngeal carcinoma.
   Zhu F, Wu Y, Wang H. · · 2023 · cited 9× · PMID 37860184 · DOI 10.3389/fonc.2023.1259331
5. Individualized Concurrent Chemotherapy for Patients with Stage III-IVa Nasopharyngeal Carcinoma Receiving Neoadjuvant Chemotherapy Combined with Definitive Intensity-Modulated Radiotherapy.
   Ji P, Lu Q, Chen X, Chen Y, et al · · 2023 · cited 1× · PMID 37170497 · DOI 10.4143/crt.2022.1651
6. Concurrent chemoradiotherapy plus nimotuzumab versus chemoradiotherapy alone for locoregionally advanced nasopharyngeal carcinoma with a suboptimal response to induction chemotherapy: a randomized phase 2 trial.
   Liu LT, Sun XS, Quan TT, Li XY, et al · · 2026 · PMID 41916997 · DOI 10.1038/s41467-026-71019-5