Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorZhejiang Provincial People's Hospital
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
pembrolizumab+cisplatin + 5-FU
Combination productivgtt, 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Pembrolizumab+cisplatin + 5-fluorouracilExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary site CR rate after neoadjuvant therapy
Measure the primary site CR rate after neoadjuvant therapy
Time frame
Up to 6 monthsSecondary outcomes
1
Incidence of adverse reactions during neoadjuvant therapy
Incidence of adverse reactions during neoadjuvant therapy
Time frame
up to 2 years2
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.
Time frame
up to 6 months3
Primary site pCR rate after neoadjuvant therapy
Primary site pCR rate after neoadjuvant therapy
Time frame
Up to 6 months4
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.
Time frame
up to 2 yearsOther outcomes
1
Exploratory Outcome2
Pembrolizumab in combination with low-dose PF (cisplatin + 5-fluorouracil) stratified by CPS PD-L1 status (CPS PD-L1\<1, CPS PD-L1\>1, and CPS PD-L1 not evaluable/uncertain) ) for the primary CR rate of stage 1 neoadjuvant therapy for locally advanced HNSCC
Time frame
Up to 6 months2
Exploratory Outcome：biomarkers and single-cell sequencing
Immune cell flow analysis, blood MRD detection analysis, single-cell sequencing analysis before and after immune neoadjuvant therapy.
Time frame
up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov