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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

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Drug: Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxel

    Drug

    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.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Experimental: Neoadjuvant Treatment + Salvage Surgery + Adjuvant TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of Major Pathological Response (mPR)

Major pathologic response (mPR) is defined as having ≤ 10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced mPR

Time frame
2 months

Secondary outcomes

1

Rate of Pathologic complete response (PCR)

Pathologic complete response (PCR) is defined as having no invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced PCR.

Time frame
2 months
2

1 year Event-free Survival (EFS) Rate

EFS is the time from the date of study entry to the date of first record of disease progression as defined by RECIST 1.1

Time frame
12 months
3

2 year Event-free Survival (EFS) Rate

EFS is the time from the date of study entry to the date of first record of disease progression as defined by RECIST 1.1

Time frame
24 months
4

1 year Overall Survival (OS) Rate

OS is the time from study entry to death due to any cause

Time frame
12 months

Other outcomes

1

Changes in the Level of biomarkers for predicting therapeutic efficacy

Changes in the Level of PD-L1 expression, tumor mutation burden, microsatellite instability, immune cell invasion

Time frame
24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: