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

NCT05446467 | Recruiting Phase 2 FDA Drug

• 1 other identifier: KPF20220630
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Primary site CR rate after neoadjuvant therapy

  Measure the primary site CR rate after neoadjuvant therapy

  Up to 6 months

Secondary Outcomes (9)

• Incidence of adverse reactions during neoadjuvant therapy

  up to 2 years

• The stages of descent after neoadjuvant therapy

  up to 6 months

• Primary site pCR rate after neoadjuvant therapy

  Up to 6 months

• EFS

  up to 2 years

• DFS

  up to 2 years

Other Outcomes (2)

• Exploratory Outcome2

  Up to 6 months

• Exploratory Outcome：biomarkers and single-cell sequencing

  up to 2 years

Study Arms (1)

Pembrolizumab+cisplatin + 5-fluorouracil

EXPERIMENTAL

Pembrolizumab+ cisplatin+ 5-fluorouracil+ surgery+ adjuvant treatment+ pembrolizumab maintenance

Combination Product: pembrolizumab+cisplatin + 5-FU

Interventions

pembrolizumab+cisplatin + 5-FU COMBINATION_PRODUCT

ivgtt, pembrolizumab 200mg d1+cisplatin20 mg/m2 qd d1-d3 + 5-fluorouracil 3000mg/m2 last for 120hours, six circles. Subjects will undergo surgery after receiving neoadjuvant chemotherapy within 3 weeks, followed by adjuvant therapy and pembrolizumab alone maintenance treatment.

Pembrolizumab+cisplatin + 5-fluorouracil

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, ≤ 85 years old
• Histologically or cytologically proven squamous cell carcinoma of the head and neck; Patients diagnosed with head and neck squamous cell carcinoma with stage III and IV A without distant metastasis according to AJCC staging (8th editon), including squamous cell carcinoma of oropharyngeal (P16-), oral cavity, hypopharyngeal and larynx
• Measurable primary lesions per RECIST 1.1 criteria
• Treatment-naive patients without any previous disease-related therapy (except for diagnostic biopsies on primary lesions)
• ECOG performance status of 0 or 1
• Selective standard surgery+ standard adjuvant chemo-radiotherapy/radiotherapy as judged by the investigator
• No active autoimmune disease
• No concurrent malignancy
• Life expectancy is estimated to be over 3 months
• Have sufficient tumour tissue samples available for CPS PD-L1 immunohistochemical examination (22C3 DAKO)
• No abvious signs of hematological disorders, ANC≥1.5×109 /L, platelets ≥100×109 /L, Hb≥ 90 g/L,WBC ≥3.0×109 /L before enrollment, no blood transfusion and bleeding tendency within 7 days
• ALT,AST and ALP ≤ 2.5 × upper limit of normal (ULN); Serum bilirubin ≤ 1.5 × ULN, for patients with known Gilbert disease, serum bilirubin ≤ 3 x ULN
• Serum creatinine ≤1.5 or creatinine clearance\>50 mL/min
• HPV status determined by p16 IHC, in situ hybridization, or by polymerase chain reaction-based assays
• Able to understand this study, patient and (or) legal representative voluntarily agree to participate in this trial and sign informed consent

You may not qualify if:

• Multiple organs failure
• HPV p16 positive oropharyngeal cancer
• Patients with local advanced head and neck squamous cell carcinoma stage T4B and/or N3
• Patients with distant metastasis
• Uncontrolled serious diseases that, as assessed by investigator, may affect the subject's treatment with the study protocol, such as serious heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.
• Diagnosis of dementia, altered mental status or any mental illness that would prevent subjects understanding or giving informed consent or completing questionnaires
• Subjects with ≥ Grade 2 peripheral neuropathy according to CTCAE V5.0
• Subjects with ≥ Grade 2 hearing impairment according to CTCAE V5.0
• History of allergy or hypersensitivity to any of the therapeutic ingredients
• Diagnosis of malignancy within 5 years prior to screening, including HNSCC (other than current HNSCC) and other malignancies; Eligibility is achieved if all of the following criteria are met: malignancies received curative therapy, such as adequately treated cervical carcinoma in situ, non-melanoma cutaneum carcinoma, localized prostate cancer after radical operation, breast ductal carcinoma in situ after radical operation; There was also no evidence of recurrence or metastasis based on imaging and tumor markers
• Known history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
• Patients diagnosed with nasopharyngeal carcinoma or squamous cell carcinoma whose lesions are located in parts other than the oral cavity, oropharynx, larynx and hypopharynx (such as sinuses, paranasal sinuses and unknown primary site)
• Participated in other clinical intervention trials or received other investigational therapies within 30 days prior to screening
• Patients received systemic corticosteroids (prednisone equivalent dose\>10mg/day) or other immunosuppressive drugs within 14 days prior to randomization. If there is no active autoimmune disease, inhaled or topical steroid hormones and adrenal hormone replacement therapy with prednisone equivalent doses\>10mg per day are permitted
• Pregnant or breastfeeding; Subjects of childbearing age refuse to accept contraceptive measures

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (7)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266555, China

NOT YET RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

Sir Run Run Shaw Hospital School of Medicine,Zhejiang University

Hangzhou, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, China

RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, China

RECRUITING

Tianjin Cancer Hospital Airport Hospital

Tianjin, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Minghua Ge, PhD

  Zhejiang Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiajie Xu, PhD

CONTACT

+86 13600517252; 03kqyxxjj@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 6, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)