Combining Penpulimab with chemotherapy for treating head and neck cancer
A Phase II Clinical Study of Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable Head and Neck Squamous Cell Carcinoma
This study is testing if combining the immunotherapy drug Penpulimab with chemotherapy can help people with head and neck cancer do better before and after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Academic / other |
| Drugs / interventions | prednisone, Penpulimab, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06081673 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of Penpulimab, an immunotherapy drug, when used alongside chemotherapy agents like cisplatin and albumin-paclitaxel in patients with resectable head and neck squamous cell carcinoma. The treatment is administered both before and after surgery to enhance patient outcomes. Participants will be closely monitored for their response to the therapy and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with untreated, pathologically confirmed stage III or IVa head and neck squamous cell carcinoma who are eligible for surgical treatment.
Not a fit: Patients with non-resectable head and neck cancers or those with significant comorbidities that affect their ability to undergo surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with head and neck cancer by enhancing the effectiveness of chemotherapy.
How similar studies have performed: While similar approaches combining immunotherapy with chemotherapy have shown promise in other cancers, this specific combination in head and neck cancer is still being explored and may be considered novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Min Ruan, PhD
- Email: doctorruanmin@situ.edu.cn
- Phone: 18019790370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.