Neoadjuvant Immunochemotherapy for LAOSCC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLai-ping Zhong
About this trial
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.
Eligibility criteria
Qualifiers
Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC 2018)
Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Disqualifiers
Unresolved grade 2 [(Common Terminology Criteria for Adverse Events (CTCAE 5.0)] or higher toxic reactions caused by previous anticancer treatments
Known allergic reaction (grade 3-4) to any ingredients or excipients of the therapy
Known history of malignancy, unless been cured and no recurrence for 5 years
Known history of radiation to head and neck
Trial design
Treatments tested in this trial
- albumin paclitaxel, cispatin, tislelizumab
Treatment groups
134 Participants
are divided into 2 treatment groupsSponsors and collaborators
Lai-ping Zhong
Lead sponsor
Huashan Hospital
Sponsor institution
Sun Yat-sen University
Collaborator
Fudan University
Collaborator
Central South University
Collaborator
Fujian Medical University
Collaborator
Source ClinicalTrials.gov