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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • tirilizumab with albumin-bound paclitaxel and cisplatin
  • surgery

Treatment groups

116 Participants
are divided into 2 treatment groups

Locations

1
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine200011, ShanghaiShanghai Municipality, China

Sponsors and collaborators

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

Lead sponsor