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Safety and Efficacy of GP Regimen Combined With Nimotuzumab and Sintilimab as Induction Therapy in Locally Advanced Nasopharyngeal Carcinoma: a Single-center, Prospective, Single-arm Phase II Clinical Study
The goal of this clinical trial is to learn if the regimen of gemcitabine, cisplatin combined with nimotuzumab and sintilimab works to treat locally advanced nasopharyngeal carcinoma before chemoradiotherapy. It will also learn about the safety of the regimen. The main questions it aims to answer are: * Does the regimen increase the number of participants who has a significant tumor shrinkage? * What medical problems do participants have when taking the regimen? Researchers will evaluate the safety and efficacy of the regimen. Participants will: * Take the regimen every 21 days, for twice. * Visit the clinic weekly for drug administration, checkups and tests. * Keep a diary of their symptoms.
The study is to investigate the efficacy and safety of combining nimotuzumab and sintilimab with the GP regimen for induction chemotherapy in patients with locally advanced nasopharyngeal carcinoma. This clinical trial adopts a single-center, prospective, single-arm phase II trial design. Each treatment cycle will be three weeks long, with a total of two cycles. After screening, eligible patients will be enrolled in the study. Patients will receive two cycles of gemcitabine, cisplatin, nimotuzumab, and sintilimab as induction therapy. Patients will undergo regular follow-up visits, and researchers will collect data on efficacy and safety. Short-term outcomes will be assessed according to the RECIST 1.1 criteria, and adverse events will be evaluated using the CTCAE 5.0.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Start Date
July 20, 2024
Primary Completion Date
July 20, 2026
Completion Date
July 20, 2027
Last Updated
July 8, 2024
20
ESTIMATED participants
GP Regimen, Nimotuzumab, Sintilimab
DRUG
Lead Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
NCT05860868
NCT05397769
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07177443