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.
This study is a prospective, single-arm, multicenter, Phase II clinical study. This study was planned to include patients with histologically confirmed non-keratinized stage TanyN2-3M0 nasopharyngeal carcinoma (AJCC Version 8). Eligible enrolled patients will receive 3 cycles of induction therapy: sintilimab, bevacizumab, and TP regimen chemotherapy. After induction therapy, all patients received radical concurrent chemoradiotherapy and maintenance treatment with sintilimab.The primary endpoint is radiographic complete response rate after induction therapy.The secondary endpoint are two years PFS rate and safety which is the incidence and severity of AE evaluated according to the NCI CTCAE (version 5.0) classification of the severity of adverse events, and the correlation with the study drugs was analyzed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Induction therapy was sintilimab 200mg IV d1, bevacizumab 7.5mg/kg IV d1, albumin-bound paclitaxel 260mg/m2 IV d1 and cisplatin 80mg/m2 IV d1, once every 3 weeks, a total of 3 cycles.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
radiographic complete response rate
CR rate was evaluated according to recist 1.1 criteria
Time frame: At the end of Cycle 3 (each cycle is 21 days)
progression-free survival
The time from the time the patient receives treatment to the time the disease progresses or death (whatever the cause)
Time frame: 2 years
AE
The incidence and severity of acute effects were evaluated according to the NCI CTCAE (version 5.0) classification of the severity of adverse events, and the correlation with the study drugs was analyzed. Safety and tolerability of changes in vital signs, physical examination, and laboratory tests during the study were evaluated according to the severity of adverse events (AE) according to NCI CTCAE (version 5.0).
Time frame: 2 years
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