Suspended

Nimotuzumab with Concurrent Chemoradiotherapy for High-Risk Locally Advanced Nasopharyngeal Carcinoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This phase 2 study aims to evaluate if adding Nimotuzumab to concurrent chemoradiotherapy can improve progression-free survival in individuals with high-risk locally advanced nasopharyngeal carcinoma.

What is being tested

CCRT+Nimotuzumab

+ CCRT alone

Drug
Who is being recruted

Nasopharyngeal Carcinoma+11

+ Carcinoma

+ Head and Neck Neoplasms

From 18 to 70 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: January 2020
See protocol details

Summary

Principal SponsorSun Yat-sen University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 31, 2020

Actual date on which the first participant was enrolled.

This clinical trial focuses on high-risk nasopharyngeal carcinoma, a type of cancer that affects the nose and throat. Despite existing treatments like induction chemotherapy combined with concurrent chemoradiotherapy, around 20-30% of patients still experience recurrence and metastasis. The study aims to improve survival rates for these high-risk patients by exploring whether increasing treatment intensity during concurrent chemoradiotherapy can be beneficial. The trial involves the use of Nimotuzumab, a drug that blocks epidermal growth factor (EGFR), a known therapeutic target for nasopharyngeal carcinoma. During the trial, participants will undergo concurrent chemoradiotherapy with or without Nimotuzumab. The primary outcome being measured is progression-free survival (PFS), which is defined from the date of randomization to the date of first documentation of progression or death due to any cause. This study hopes to provide new evidence for individualized comprehensive treatment of locally advanced nasopharyngeal carcinoma.

Official TitleRandomized Phase II Trial of Concurrent Chemoradiotherapy With or Without Nimotuzumab for High Risk Nasopharyngeal Carcinoma After Induction Chemotherapy
NCT04223024
Principal SponsorSun Yat-sen University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

246 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nasopharyngeal CarcinomaCarcinomaHead and Neck NeoplasmsStomatognathic DiseasesNasopharyngeal DiseasesNasopharyngeal NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsPharyngeal DiseasesPharyngeal Neoplasms

Criteria

9 inclusion criteria required to participate
Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma with positive EGFR expression, type of WHO II or III, clinical stage II-IVa (according to the 8th American Joint Committee on Cancer[AJCC] edition)

ECOG (Eastern Cooperative Oncology Group) score: 0-1

Hemoglobin (HGB) >= 90 g/L, white blood cell (WBC) >= 4x109 /L, platelet (PLT) >= 100x109 /L

Age 18-70, regardless of sex

Show More Criteria

10 exclusion criteria prevent from participating
Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant

Histologically confirmed keratinizing squamous cell carcinoma (WHO I)

Receiving radiotherapy or chemotherapy or targeted therapy previously

Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This group is for patients who didn't improve after initial chemotherapy. They will receive a combination of cisplatin and nimotuzumab during radiotherapy.

Group II

Active Comparator
This group receives cisplatin along with intensity modulated radiotherapy. This treatment is given to patients whose plasma EBV DNA is greater than 0 copy/mL or have SD/PD according to RECIST after two cycles of induction chemotherapy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sun Yat-sen Universitty Cancer Center

Guangzhou, ChinaOpen Sun Yat-sen Universitty Cancer Center in Google Maps
SuspendedOne Study Center