Neoadjuvant immunochemotherapy for advanced oral cancer

Neoadjuvant Immunochemotherapy With Tislelizumab, Albumin Paclitaxel and Cisplatin Followed by Standard Therapy Versus Standard Therapy for Locally Advanced Oral Squamous Cell Carcinoma, a Multicenter Randomized Phase 3 Trial

This study is testing a new combination of immunotherapy and chemotherapy to see if it can shrink tumors in people with advanced oral cancer before they have surgery, and if it helps them live longer compared to standard treatments.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Huashan Hospital (other)
• Drugs / interventions: radiation, tislelizumab, tiralizumab, chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06258811 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of neoadjuvant immunochemotherapy using tislelizumab, albumin paclitaxel, and cisplatin in patients with locally advanced oral squamous cell carcinoma (LAOSCC). The approach aims to reduce tumor size before radical surgery and assess the impact on survival rates compared to standard therapy. The study builds on previous findings that suggest neoadjuvant immunochemotherapy may offer better outcomes than other treatment modalities. Participants will undergo treatment followed by surgery and adjuvant therapy, with a focus on measuring the two-year survival rate.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of LAOSCC who have a clinical stage of III/IVA and meet specific health criteria.

Not a fit: Patients with unresolved grade 2 adverse effects or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with locally advanced oral squamous cell carcinoma.

How similar studies have performed: Previous studies have shown promising results for neoadjuvant immunochemotherapy in similar patient populations, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
2. Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
3. Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC 2018)
4. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
5. Blood routine: white blood cells (WBCs) \>3,000/mm3, hemoglobin \>8 g/L, platelets \>80,000/mm3
6. Liver function: alanine amino transferase/aspartate amino transferase (ALAT/ASAT) \<2.5 times the upper limit of normal and bilirubin \<1.5 times the upper limit of normal
7. Renal function: Serum creatinine \<1.5 times the upper limit of normal
8. Coagulation function: INR、PT、APTT\<1.5 times the upper limit of normal
9. Signed the informed consent form

Exclusion Criteria:

1. Unresolved grade 2 \[(Common Terminology Criteria for Adverse Events (CTCAE 5.0)\] or higher toxic reactions caused by previous anticancer treatments
2. Known allergic reaction (grade 3-4) to any ingredients or excipients of the therapy
3. Known history of malignancy, unless been cured and no recurrence for 5 years
4. Known history of radiation to head and neck
5. Active severe clinical infection (\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)
6. Obvious cardiovascular abnormalities \[such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment\]
7. Patients receiving immunology-based treatment for any reason
8. Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
9. Pregnant or lactating women
10. Known active hepatitis B or C. Active hepatitis B is defined as a known HBsA positive with HBV DNA≥500 IU/mL. Active hepatitis C is defined as a known hepatitis C antibody positive and a known amount of hepatitis C virus HCV RNA results greater than the lower limit of detection. The presence of other serious liver diseases, including chronic autoimmune liver disease, primary biliary cirrhosis or sclerosing cholangitis, alcoholic liver disease, or non-alcoholic steatohepatitis (NASH)
11. Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation
12. Participation in other clinical trials within 30 days before enrollment
13. Other situations that the investigator considers unsuitable with respect to participating in the trial

Where this trial is running

Shanghai

• Huashan Hospital, Fudan University — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Lai-ping Zhong, MD, PhD — Huashan Hospital
• Study coordinator: Lai-ping Zhong, MD, PhD

Conditions: Oral Squamous Cell Carcinoma, Locally Advanced Head and Neck Carcinoma, Oral squamous cell carcinoma, Neoadjuvant immunochemotherapy