Nimotuzumab with Concurrent Chemoradiotherapy for High-Risk Locally Advanced Nasopharyngeal Carcinoma
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.
CCRT+Nimotuzumab
+ CCRT alone
Nasopharyngeal Carcinoma+11
+ Carcinoma
+ Head and Neck Neoplasms
Prevention Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.246 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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
Sun Yat-sen Universitty Cancer Center
Guangzhou, ChinaOpen Sun Yat-sen Universitty Cancer Center in Google Maps