NCT06081673 Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC
| NCT ID | NCT06081673 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2023-10-30 |
| Primary Completion | 2024-12-30 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 72 participants in total. It began in 2023-10-30 with a primary completion date of 2024-12-30.
⚠ 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 aims to observe and explore the efficacy and safety of Penpulimab combined with chemotherapy for neoadjuvant and adjuvant therapy in patients with resectable head and neck squamous cell carcinoma.
Eligibility Criteria
Inclusion Criteria: * Patients voluntarily joined the study, signed the informed consent, and had good compliance; * Patients with 18 Years to 75 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-1; * Patients with untreated head and neck squamous cell carcinoma who were pathologically confirmed and determined to be suitable for surgical treatment were classified as stage III, IVa according to AJCC (8th Edition), including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers * Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study. Exclusion Criteria: * Patients who have previously used PD-1/PD-L1/CTLA-4 antibody therapy; * Patients who require systemic treatment with corticosteroids (\> 10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days prior to administration or during treatmentIn the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone at doses \>10mg/ day equivalent to prednisone and adrenocortical hormone replacement at therapeutic doses not exceeding 10mg/ day prednisone are permitted; * A history of any active immune or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; * Active or uncontrolled severe infection within 4 weeks prior to enrollment (CTCAE grade 2 infection); * Abnormal function of major organs * Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06081673 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, 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 NCT06081673 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06081673 currently recruiting?
Yes, NCT06081673 is actively recruiting participants. Contact the research team at doctorruanmin@situ.edu.cn for enrollment information.
Where is the NCT06081673 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06081673 clinical trial?
NCT06081673 is sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. The trial plans to enroll 72 participants.