Overview
A phase Ⅱ open label multi-cencter clinical trail to evaluate the efficacy and safety of pembrolizumab combined with low-dose PF (cisplatin + 5-fluorouracil) in the neoadjuvant treatment of locally advanced head and neck squamous cell carcinoma
Description
The investigatorsdesigned a multi-center, single-arm, small sample clinical pilot study. In the clinical trial, patients were given regimes of induction therapy with PLPF (Pembrolizumab + Low dose- P (Platinum) F (5-Fluorouracil)): 6 cycles of Pembrolizumab treatment. Herein, the investigators describe eight consecutive unselected LA SCCHN (Locally Advanced Head and Neck Squamous Cell Carcinoma) patients based on 6 completed cycles of PLPF induction therapy.
Eligibility
Inclusion Criteria:
- Age ≥ 18 years old, ≤ 85 years old
- Histologically or cytologically proven squamous cell carcinoma of the head and neck(except T4b stage patients)
- Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx. (Although they are admittedly of squamous cell types, the following tumors will be excluded because of the Y responsiveness to chemotherapy: tumors of the nasal and paranasal cavities, larynx and of the nasopharynx.)
- At least one measurable lesion.
- No previous chemotherapy, radiotherapy or surgery (other than biopsy) for SSCHN.
- ECOG performance status of 0 or 1.
- No active autoimmune disease
- No concurrent malignancy
- Life expectancy of greater than 12 weeks.
- Adequate bone marrow, hepatic and renal functions.
- Available for treatment and follow-up.
Exclusion Criteria:
- Multiple organs failure.
- distant metastases HNSCC.
- HPV p16 positive oropharyngeal cancer
- T4B advanced head and neck squamous cell carcinoma
- Current severe, uncontrolled systemic disease.
- Hepatitis B or active hepatitis C
- Mental illness.
- Peripheral neuropathy with CTCAE V5.0 ≥ level 2.
- History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies that required discontinuation of therapy.
- Malignancies other than SCCHN within 5 years prior to enrollment.
- Nasopharyngeal cancer.
- Pregnant or lactating women.