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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06258811
Other study ID # TopHill
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 20, 2024
Est. completion date December 30, 2028

Study information

Verified date February 2024
Source Huashan Hospital
Contact Lai-ping Zhong, MD, PhD
Phone +862152888915
Email zhonglp@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the prognostic efficacy of neoadjuvant immunochemotherapy with tislelizumab, albumin paclitaxel and cisplatin followed by radical surgery and adjuvant therapy compared with standard therapy for patients with locally advanced and resectable oral squamous cell carcinoma.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
albumin paclitaxel, cispatin, tislelizumab
Neoadjuvant immunochemotherapy (2 cycles, and 21 days each cycle, 260mg/m2 albumin paclitaxel intravenously on day 1 and day 22, with 75mg/m2 of cisplatin and 200mg of tislelizumab) + radical surgery + adjuvant therapy (radiation/chemoradiation followed by 200mg of tislelizumab, every 3 weeks for one year)

Locations

Country Name City State
China Huashan Hospital, Fudan University Shanghai

Sponsors (5)

Lead Sponsor Collaborator
Lai-ping Zhong Central South University, Fudan University, Fujian Medical University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of 2-year event-free survival Event free survival is calculated from the date of randomization to local recurrence, regional recurrence, distant metastasis, disease progress, or death. The rate of 2-year event free survival is reported as the percentage of patients who are event free survival for 2 years from the date of randomization. 2 years
Primary Rate of 2-year overall survival Overall survival is calculated from the date of randomization to death. The rate of 2-year overall survival is reported as the percentage of patients who are overall survival for 2 years from the date of randomization. 2 years
Secondary Rate of 2-year disease-free survival Disease free survival is calculated from the date of randomization to local recurrence, locoregional recurrence, distant metastasis, or death. The rate of 2-year disease free survival is reported as the percentage of patients who are disease free survival for 2 years from the date of randomization. 2 years
Secondary Rate of major pathological response Major pathological response is based on the pathological examination on the post-operative specimens after neoadjuvant immunochemotherapy. The rate of major pathological response is reported as the percentage of patients who have major pathological response after NAT. 6 months
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