Tirilizumab with Albumin-bound Paclitaxel and Cisplatin for Locally Advanced Resectable Oral Squamous Cell Carcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

June 19, 2024

Primary Completion Date

June 19, 2025

Study Completion Date

June 19, 2027

Conditions
Locally Advanced Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

tirilizumab with albumin-bound paclitaxel and cisplatin

tirilizumab administered by intravenous drip (no prophylaxis required) at a fixed dose of 200 mg. each infusion was given for 30 min (not less than 20 min and not more than 60 min) every 3 weeks, and 3 preoperative cycles of albumin-bound paclitaxel 260 mg/m2 and cisplatin 75 mg/m2 on d1, with 1 cycle every 21 days; 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed.

PROCEDURE

surgery

patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.

Trial Locations (1)

200011

RECRUITING

the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

All Listed Sponsors
lead

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER