NCT06102395 Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC
| NCT ID | NCT06102395 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beijing Tongren Hospital |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 272 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 272 participants in total. It began in 2023-05-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Zhigang Huang
STUDY CHAIR
Beijing Tongren Hospital
Frequently Asked Questions
Who can join the NCT06102395 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06102395 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 272 participants.
Is NCT06102395 currently recruiting?
Yes, NCT06102395 is actively recruiting participants. Contact the research team at huangzhigang1963@sohu.com for enrollment information.
Where is the NCT06102395 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06102395 clinical trial?
NCT06102395 is sponsored by Beijing Tongren Hospital. The principal investigator is Zhigang Huang at Beijing Tongren Hospital. The trial plans to enroll 272 participants.