NCT06490341

GP Combined With Nimotuzumab and Sintilimab as Induction Therapy for Nasopharyngeal Carcinoma

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Locally Advanced Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	GP Regimen, Nimotuzumab, Sintilimab	gemcitabine,ciplatin, nimotuzumab, sintilimab

Timeline

• Start date: 2024-07-20
• Primary completion: 2026-07-20
• Completion: 2027-07-20
• First posted: 2024-07-08
• Last updated: 2024-07-08