Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma

• Status: Not yet recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the safety and feasibility of neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy in subjects with resectable local advanced oral squamous cell carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital of Stomatology, Wuhan University
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

Inclusion Criteria:

1. Histologically documented oral squamous cell carcinoma (biopsy required).

2. Local advanced oral squamous cell carcinoma (clinical stage T1-2N1-3M0, T3-4aN0-3M0) 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.