A Prospective, Randomised Controlled, Phase II Clinical Study of Tirilizumab in Combination With Albumin-bound Paclitaxel With Cisplatin for Neoadjuvant and Adjuvant Treatment of Locally Advanced Resectable Oral Squamous Cell Carcinoma
NCT Number: NCT06470217
Acronym: OPTimal
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Interventions: DRUG: tirilizumab with albumin-bound paclitaxel and cisplatin|PROCEDURE: surgery
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 116
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2027-06-19
Locations: the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200011, China

Summary:
The dosing regimen in the trial group was: tirilizumab with albumin-bound paclitaxel and cisplatin for 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.

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

Primary Outcome Measures: 2 year events free survival rate, the percentage of participants documented PD per RECIST 1.1 from enrollment in the neoadjuvant stage, or recurrent or death due to any cause, whichever occurred first., up to 36 months
Secondary Outcome Measures: overall survival, OS was defined as the time from enrollment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up., 36 months|Number of Participants Experiencing an Adverse Event (AE), An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm., 36 months|Quality of life EORTC QLQ-C30 scale, The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent), 36 months|MPR rate, the percentage of participants viable tumour cells remaining in the tumour bed after neoadjuvant therapy ≤10%, regardless of the presence or absence of viable tumour cells in the lymph nodes, 36 months