Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCC

• Status: Not yet recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Zhejiang Provincial People's Hospital
• Treatments: Fluorouracil; Pembrolizumab

Criteria

Inclusion Criteria:

• Age ≥ 18 years old, ≤ 85 years old Histologically or cytologically proven squamous cell carcinoma of the head and neck.Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx. Although they are admittedly of squamous cell types, the following tumors will be excluded because of theY 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. Life expectancy of greater than 12 weeks. Adequate bone marrow, hepatic and renal functions. Patients must be available for treatment and follow-up.

Exclusion Criteria:

• Patients with multiple organs failure. SCCHN with distant metastases. Current severe, uncontrolled systemic disease. 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.