Combining Tislelizumab with Chemotherapy for Advanced Head and Neck Cancer
Neoadjuvant Tislelizumab (BGB-A317, Anti-PD-1 Antibody) Plus Nab-Paclitaxel and Carboplatin for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma : A Single-arm, Phase II Trial
This study is testing if combining a new immunotherapy drug with chemotherapy can help people with advanced head and neck cancer do better before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | chemotherapy, tislelizumab |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06235918 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of neoadjuvant immunochemotherapy using tislelizumab combined with a platinum-based chemotherapy regimen for patients with resectable locally-advanced head and neck squamous cell carcinoma. The study aims to improve treatment outcomes for this patient population by assessing the response to this novel therapeutic approach before surgical intervention. Participants will receive the treatment and be monitored for safety and efficacy, with the goal of enhancing the overall management of their condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage III-IVA resectable head and neck squamous cell carcinoma and an ECOG performance status of 0-1.
Not a fit: Patients with prior systemic anti-cancer therapy for head and neck squamous cell carcinoma or those with abnormal organ function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and survival rates for patients with advanced head and neck cancer.
How similar studies have performed: Other studies have shown promise in using neoadjuvant immunotherapy combined with chemotherapy for similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who voluntarily participate in the project and sign the informed consent. 2. Be 18 years of age on day of signing informed consent. 3. The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1. 4. According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVA tumors confirmed by pathology as head and neck squamous cell carcinoma. 5. Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis. 6. Demonstrate adequate organ function. Exclusion Criteria: 1. The patient has abnormal blood indicators, abnormal liver and kidney function. 2. The patient has received prior systemic anti-cancer therapy for head and neck squamous cell carcinoma including investigational agents within 3 months of first dose of study treatment. 3. The patient has previously suffered from other tumors , or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy within the past 5 years. 4. The entire clinical research process cannot be completed due to personal, social and economic reasons. 5. Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs .
Where this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Guangyuan Hu, professor — Tongji Hospital
- Study coordinator: Xiang Lu, professor
- Email: luxiangent@hotmail.com
- Phone: 027-83662691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.