Pembrolizumab: Pembrolizumab 200mg, IV, on day1 of Q3W, 2 cycle
Cisplatin: Cisplatin 75 mg/m\^2, IV, day 1 of Q3W
Carboplatin: Carboplatin AUC (area under curve) 2, IV, day 1-3 of Q3W
Nedaplatin: Nedaplatin 80-100 mg/m\^2, IV, day 2-4 of Q3W
Nab paclitaxel: Nab paclitaxel 260 mg/m\^2, IV, day 1 of Q3W
Docetaxel: Docetaxel 75 mg/m\^2, IV, day 1 of Q3W
Liposomal paclitaxel: Liposomal paclitaxel 135-175 mg/m\^2, IV, day 1 of Q3W
Fluorouracil: Fluorouracil 750 mg/m\^2, IV, day 1-5 of Q3W
Study summary
This study is a prospective, open-label, multi-center phase III study; patients with untreated stage IIIA to stage IVB head and neck squamous cell carcinoma (including oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer) who meet the inclusion criteria are randomized 1:1 and given pembrolizumab 200 mg d1+ chemotherapy for 2 cycles (experimental group), 2 cycles of chemotherapy (control group), and then stratified according to the patient's condition. If the imaging evaluation after neoadjuvant treatment is (complete response, CR), adjuvant radiotherapy will be given; if the imaging evaluation is (partial response, PR) or (stable disease, SD), surgery (within 2 weeks) will be performed, followed by standard treatment. The main research hypothesis of this study: pembrolizumab combined with standard chemotherapy can significantly improve the rate of pathological complete response (pCR) compared with standard chemotherapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients with stage IIIA-IVB head and neck squamous cell carcinoma confirmed by histology and/or cytology;
2. Have not received immunotherapy in the past;
3. The researchers believe that he can safely receive pembrolizumab combined with chemotherapy or neoadjuvant chemotherapy;
4. Age ≥18 years;
5. ECOG 0-2;
6. Measurable disease as defined by RECIST v1.1;
7. Organs function normally;
8. Female and male participants of reproductive potential must agree to use appropriate contraception throughout the study period and for 180 days after the last study treatment;
9. Male participants must not donate sperm throughout the study and for 180 days after the last study treatment.
Exclusion Criteria:
1. Presence of distant metastasis;
2. Female subjects with a positive urine pregnancy test within 72 hours before the start of the study or within 24 hours after starting radiation therapy (with or without cisplatin);
3. received a live vaccine within 30 days before enrollment;
4. Diagnosed with immunodeficiency or receiving systemic steroid treatment or any other form of immunosuppressive treatment within 7 days before enrollment;
5. Have imaging detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or cancerous meningitis;
6. Have undergone surgery before commencing the study or have failed to recover adequately from toxicity or complications resulting from the intervention;
7. Previous allogeneic tissue/solid organ transplant;
8. Severe hypersensitivity reaction (≥Grade 3) to pembrolizumab or any of its excipients, radiotherapy, platinum, paclitaxel, 5-FU or their analogs;
9. Have an active autoimmune disease requiring systemic therapy in the past 2 years;
10. History of (non-infectious) pneumonia requiring steroid treatment;
11. Have a history of human immunodeficiency virus (HIV) infection;
12. Have a history of hepatitis B or be positive for hepatitis B virus (defined as a positive reaction to hepatitis B surface antigen \[HBsAg\]) or active hepatitis C (defined as detection of hepatitis C virus \[HCV\] ribonucleic acid).
13. Have any medical history, treatment, or laboratory abnormalities that could confound the study results, interfere with participant participation throughout the study, or be detrimental to the best interests of the participant (e.g., Hashimoto's thyroiditis, etc.);
14. Have a known history of mental illness or substance abuse disorder
Primary outcome measure(s)
Pathological complete response rate (pCR) of pembrolizumab combined with standard chemotherapy neoadjuvant therapy in patients with locally advanced head and neck squamous cell carcinoma — 12 week pCR was defined as the absence of residual invasive squamous cell carcinoma within the primary tumor specimen on resection/needle biopsy
Pathological complete response rate (pCR) of standard chemotherapy neoadjuvant chemotherapy in patients with locally advanced head and neck squamous cell carcinoma — 12 week pCR was defined as the absence of residual invasive squamous cell carcinoma within the primary tumor specimen on resection/needle biopsy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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