Trials / Not Yet Recruiting

Not Yet RecruitingNCT06728618

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

A Single-Arm, Prospective Phase II Clinical Study on the Neoadjuvant Tislelizumab -Cetuximab - TP(cisplatin and Albumin-paclitaxel) Followed by Salvage Surgery and Adjuvant Tislelizumab -Cetuximab for Resectable, Locally Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma

Status: Not Yet Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 28 (estimated)

Sponsor: Shanghai Zhongshan Hospital · Academic / Other
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

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.

Detailed description

Despite multimodality curative approaches to treat patients with oral/oropharyngeal squamous cell carcinoma (OSCC), approximately 30-40% of patients recur locally. Recurrent OSCC contributes to significant morbidity and portends overall poor survival, reflecting a situation that is difficult to treat owing to the effects of prior therapy (surgery, radiation, and/or chemotherapy) on the delicate structures of the head and neck. Both the NCCN and the CSCO head and neck cancer treatment guidelines recommend salvage surgery as a Grade I recommended curative treatment method whenever possible, as this has been shown to have a significantly better outcome as compared to patients treated non-surgically with radiation therapy with or without concurrent chemotherapy. However, salvage surgery is extremely challenging due to delicate structures of the head and neck. Previous studies have recommended that the combination of targeted therapy (cetuximab) and chemotherapy (cisplatin, paclitaxel) has effective anti-tumor effects for recurrent/metastatic head and neck squamous cell carcinoma. Recently, newer approaches also have shown favorable safety and evidence of pathologic response when using immune-checkpoint inhibitors as neoadjuvant therapy prior to upfront, curative-intent surgery in resectable head and neck cancer. Immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. Locally recurrent patients undergoing salvage therapy are understudied and deserves further exploration. This is a prospective, open label, single arm, phase II, single center interventional study of neoadjuvant combination therapy of immunotherapy (Tislelizumab), targeted therapy (cetuximab), with chemotherapy (cisplatin and nab-paclitaxel) followed by salvage surgery and followed by adjuvant immunotherapy (Tislelizumab), targeted therapy (cetuximab) in patients with resectable recurrent oral/oropharyngeal squamous cell carcinoma.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2024-12-01
Primary completion: 2026-05-01
Completion: 2028-03-01
First posted: 2024-12-11
Last updated: 2024-12-11

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06728618. Inclusion in this directory is not an endorsement.