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Head and Neck Squamous Cell CarcinomaPhase 2NCT05446467

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

A Phase 2 study testing pembrolizumab+cisplatin + 5-FU in people with Head and Neck Squamous Cell Carcinoma, run by Zhejiang Provincial People's Hospital at 7 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
pembrolizumab+cisplatin + 5-FU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
7 sitesChina
Study dates
1 Sep 2022to 1 Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • Patients unfit for study as assessed by the investigator
  • Received systemic antibiotics within 1 weeks prior to first dose of study therapy or active infection requiring treatment
  • Known history of HBV infection (defined as HBsAg positive) or active HCV infection (defined as HCV RNA detected)
  • Has received live vaccine during study or within 30 days prior to first dose of study therapy

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jiajie Xu, PhD contact

+86 13600517252

03kqyxxjj@163.com

7 sites in 1 country

China7 sites, 7 recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

    Minghua Ge, +86 13605813782, gemingh@163.com

    Jiajie Xu

    Recruiting

  • Sir Run Run Shaw Hospital School of Medicine,Zhejiang University

    Hangzhou

    Mang Xiao

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou

    Chenping Zhang

    Recruiting

  • Ningbo Medical Center Lihuili Hospital

    Ningbo

    Zhisen Shen

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266555

    Keqian Zhi, 86+ 18661800582, zhikeqian@sina.com

    Zhi

    Not yet recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin

    Wenchao Zhang

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

    Renyu Lin

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of Pembrolizumab in Combination With Low-dose PF (Cisplatin and 5-Fluorouracil) as Neoadjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma: a Multi-center, Single-arm Clinical Study Trial

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

Read the detailed 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.

Being tested
pembrolizumab+cisplatin + 5-FU
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pembrolizumab+cisplatin + 5-FUCombination 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.

Study groups in NCT05446467
Study groupRoleWhat they receive
Pembrolizumab+cisplatin + 5-fluorouracilExperimentalPembrolizumab+ cisplatin+ 5-fluorouracil+ surgery+ adjuvant treatment+ pembrolizumab maintenance
Receives: Combination Product: pembrolizumab+cisplatin + 5-FU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary site CR rate after neoadjuvant therapy

    Measure the primary site CR rate after neoadjuvant therapy

    Measured: Up to 6 months

Secondary outcomes (9)

  1. Incidence of adverse reactions during neoadjuvant therapy

    Incidence of adverse reactions during neoadjuvant therapy

    Measured: up to 2 years

  2. The stages of descent after neoadjuvant therapy

    The stage of the tumor after neoadjuvant therapy according to the American Joint Committee on Cancer (AJCC) TNM staging system (8th edition) will be evaluated by treating physicians.

    Measured: up to 6 months

  3. Primary site pCR rate after neoadjuvant therapy

    Primary site pCR rate after neoadjuvant therapy

    Measured: Up to 6 months

  4. EFS

    EFS is defined as the time from the initial treatment date to the first documented event date, including disease progression, local or distant metastasis as assessed by image or biopsy, or death from any cause, whichever comes first.

    Measured: up to 2 years

  5. DFS

    DFS is defined as the time from surgery to disease progression or death due to any cause, whichever comes first.

    Measured: up to 2 years

  6. PFS

    PFS is defined as the time from initial treatment to disease progression or death from any cause, whichever comes first.

    Measured: up to 2 years

  7. OS

    OS is defined as the time from initial treatment to death due to any cause.

    Measured: 2 years

  8. One year local control rate

    One year local control rate

    Measured: up to 6 months

  9. 1-, 2-year survival rates

    1-, 2-year survival rates

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start1 Sep 2022
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05446467
Sponsor's protocol ID
KPF20220630
Status last verified
Aug 2025
First submitted
30 Jun 2022
Last updated
20 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pembrolizumab+cisplatin + 5-FU in people with Head and Neck Squamous Cell Carcinoma, run by Zhejiang Provincial People's Hospital at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jiajie Xu, PhD (+86 13600517252, 03kqyxxjj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary site CR rate after neoadjuvant therapy (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05446467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.

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