drugset / Trial / NCT06752382

Sintilimab Combined With Bevacizumab and TP Chemotherapy in the Treatment of High Risk Locally-advanced NPC

NCT06752382 ↗

Phase 2 Not yet recruiting 58 enrolled Zhejiang Cancer Hospital
NaSingle-groupOpen-labelTreatment

Summary

Nearly half of the world's nasopharyngeal cancer occurs in China, among which the highest incidence in Guangdong and Guangxi, so the nickname "Guangdong tumor". Due to the hidden position of the nasopharynx, 70% to 80% of patients are found in the middle and late stages. Immunotherapy plays a significant role in nasopharyngeal carcinoma. Professor Ma Jun of Sun Yat-sen University reported a phase 3 clinical study at ASCO meeting in 2023, which compared the efficacy of Sintilimab combined with GP chemotherapy versus GP chemotherapy alone in locally advanced nasopharyngeal carcinoma, and the results showed that EFS in the immune group decreased by 41% in 3 years. The risk of local recurrence-free survival and distant metastasis was reduced by 48% and 43%, respectively. However, a subgroup analysis of the study found that low-risk patients benefited more, while N2-N3 patients benefited only HR There is 0.78, new treatment options need to be explored in clinic. Therefore, the investigators plan to initiate a prospective study to evaluate the efficacy and safety of Sintilimab Combined With Bevacizumab and TP Chemotherapy for high-risk locally advanced nasopharyngeal carcinoma.

Timeline

Start
2024-12-31
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Cisplatin Other / unclassified 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 260 mg/m2 Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous