Preoperative Tislelizumab -Cetuximab - Chemotherapy Followed by Salvage Surgery and Adjuvant Tislelizumab -Cetuximab for Resectable, Locally Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma

ConditionsOral Squamous Cell Carcinoma (OSCC)Oropharyngeal Squamous Cell Carcinoma (SCC)Resectable Oral and Oropharyngeal Squamous Cell Carcinoma Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShanghai Zhongshan Hospital

About this trial

The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Tislelizumab), targeted therapy (Cetuximab), with chemotherapy (Cisplatin and Nab-paclitaxel) as a possible treatment before and after salvage surgery for locally recurrent oral/pharyngeal squamous cell carcinoma. The combination of Tislelizumab，Cetuximab, Cisplatin and Nab-paclitaxel will be given prior to your surgery, while Tislelizumab and Cetuximab will be continued for approximately half a year after surgery.

Eligibility criteria

Qualifiers

Participants must have histologically or cytologically confirmed locoregionally recurrent oral/oropharyngeal squamous cell carcinoma (including tongue, lips, gums, cheeks, floor of mouth, hard palate, soft palate, posterior molar area, lateral pharyngeal wall, posterior pharyngeal wall, tonsils).

Participants must have documented time of ≥ 16 weeks from completion of prior curative intent treatment for OSCC (surgery and/or radiation therapy with/without platinum chemotherapy or cetuximab targeted therapy) to diagnosis of local or locoregional recurrence.

Age ranges from 18 to 75 years old

ECOG performance status 0 or 1.

Disqualifiers

Has known distant metastasis of the disease.

Has received chemotherapy or radiotherapy for curative treatment of oral/oropharyngeal squamous cell carcinoma within the 16 weeks prior to enrollment in the study.

Has received therapy treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody acting on T cell co stimulatory or checkpoint pathways).

Has received live or attenuated vaccines within 30 days prior to the first dose of Tislelizumab, inactivated vaccines are allowed.

Trial design

Treatments tested in this trial

Drug: Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxel

Treatment groups

28 Participants

are divided into 1 treatment group

Sponsors and collaborators

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov