Neoadjuvant Anti-PD-1 Immunotherapy With Chemotherapy in Resectable Locally Advanced Oral Squamous Cell Carcinoma

Launched by HOSPITAL OF STOMATOLOGY, WUHAN UNIVERSITY · Mar 22, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with locally advanced oral squamous cell carcinoma, a type of mouth cancer that can be surgically removed. The study aims to see if combining an immunotherapy drug called anti-PD-1 with chemotherapy improves survival compared to using chemotherapy alone or undergoing surgery first. The trial is currently looking for participants aged 18 to 75 who have been diagnosed with this type of cancer and are eligible for surgery. To join, patients must meet certain health criteria, including having a specific type and stage of cancer, and must be in good overall health.

Participants in this trial will receive either the combination of immunotherapy and chemotherapy or just chemotherapy. They will be closely monitored throughout the study to assess the effectiveness of the treatments and any side effects they may experience. It’s important for potential participants to understand the study requirements and risks, and they will need to provide informed consent before starting. This trial represents a hopeful step in finding more effective treatments for this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically documented oral squamous cell carcinoma (biopsy required).
• • 2. Local advanced oral squamous cell carcinoma (clinical stage T1-2N1-2M0, T3-4aN0-2M0) with resection option for potential cure, as assessed by a faculty surgeon at Hospital of Stomatology, Wuhan University.
• • 3. Distant metastasis is excluded by chest CT and emission computed tomograph.
• • 4. Adequate organ function as follows: 1) Leukocyte count ≥ 2,000/mm3; 2) Absolute neutrophil count ≥ 1,000/mm3; 3) Platelet count ≥ 100,000/mm3; 4) Hemoglobin ≥ 90 g/L; 5) Serum albumin ≥30 g/L; 6) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); 7) AST (SGOT) and ALT (SGPT) \< 2.5 × ULN; 8) ALP ≤ 2.5 × ULN; 9) Prothrombin time-international normalized ratio ≤ 1.5; 10) Serum creatinine ≤ 1.5 × ULN; 11) INR/PT≤ 1.5; 12) TSH ≤ ULN.
• • 5. ECOG performance status 0-1.
• • 6. Female patient tested HCG negative in serum or urine within 7 days prior to the start of investigational product. Both patient and partner must agree to use contraception prior to study entry and for the duration of study participation and for up to 120 days after the last dose of PD-1 blockade.
• • 7. Patient understands the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form.
• Exclusion Criteria:
• • 1. History of ≥ 3 grade immune related adverse events (irAEs) or have not recovered to ≤ 1 grade irAEs from previous treatment.
• • 2. History of other treatments for cancer, including surgery, chemotherapy, radiotherapy or molecular targeted therapy within past 5 years.
• • 3. Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody targeting T cell co-regulatory pathways.
• • 4. Active autoimmune disease or history of refractory autoimmune disease.
• • 5. Active systemic infection requiring therapy.
• • 6. Patients who are receiving psychotropic drug or alcohol/drug abuse.
• • 7. Subjects with concurrent other active malignancies.
• • 8. HIV or untreated active HBV or HCV infections, or vaccinated (HBV, flu, varicella, etc) within 4 weeks before recruitment.
• • 9. Uncontrollable systemic diseases, including diabetes, hypertension, etc.
• • 10. History of stroke or transient ischemic attack within past 6 months.
• • 11. Distant metastases or inability to resect after physician evaluation.
• • 12. Serious cardiovascular, respiratory, immune system critical disease or other conditions that the researchers thought might increase the subjects' risk.