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

NCT06728618 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-12-11

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Drug: Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxel

Neoadjuvant treatment: the participants will receive Tislelizumab 200 mg, Cisplatin 75 mg/m2, Nab-paclitaxel 260 mg/m2 (each 3-week cycle) and Cetuximab (400 mg/m2 first time and followed 250 mg/m2, day 1, day 8, day 15) for 2 cycles. Adjuvant treatment: the participants will receive Tislelizumab 200 mg (each 3-week cycle, a total of 8 cycle) and Cetuximab (250 mg/m2, each 2-week, a total of 12 cycle) for a total of half a year.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2026-05-31
Completion
2028-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06728618 on ClinicalTrials.gov