Neoadjuvant treatment for head and neck cancer using Camrelizumab with chemotherapy

An Open Label, Single Arm Phase II Study of Camrelizumab in Combination With Cisplatin and Nab-paclitaxel as a Novel Neoadjuvant Pre-Surgical Therapy for Resectable HNSCC

This study is testing if adding a new drug called Camrelizumab to standard chemotherapy before surgery can help people with head and neck cancer have better treatment results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Camrelizumab, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04826679 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the effectiveness and safety of administering Camrelizumab in combination with cisplatin and nab-paclitaxel before surgery in patients with resectable head and neck squamous cell carcinoma (HNSCC). The study will enroll 53 patients with specific tumor characteristics and evaluate the primary outcome of objective response rate. Participants will receive the treatment regimen prior to surgical intervention, aiming to improve surgical outcomes and overall patient prognosis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with resectable head and neck squamous cell carcinoma classified as T2N2-3M0 or T3-4N0-3M0.

Not a fit: Patients with distant metastasis or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could enhance the effectiveness of surgery and improve survival rates for patients with head and neck cancer.

How similar studies have performed: Other studies have shown promising results with similar neoadjuvant therapies in head and neck cancers, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria：

1. Confirmed pathologic and/or cytologic diagnosis of squamous cell carcinoma of head and neck，T2N2-3M0、T3-4N0-3M0（III-IV）（AJCC 8.0）
2. Greater than or equal to 18 and less than 65 years of age at time of study entry.
3. ECOG performance status of 0 or 1.
4. Resectable or potentially resectable lesion, without distance metastasis;
5. Measurable disease as per RECIST 1.1.
6. Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
7. Adequate hepatic、cardiac、brain and renal function as demonstrated by 1) Hematology: WBC≥4000/μL、NE≥2.000/μL、HGB≥9 g/dL、PLT≥100000/μL； 2) Renal: Serum creatinine \< 1.5x ULN or CrCl \> 60mL/min (if using the Cockcroft-Gault formula below): 3) Hepatic: Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3 x ULN)；AST/ALT ≤ 3 x ULN and ALP≤3 x ULN；ALB≥3g / dL；
8. Ability to understand and willingness to sign an IRB approved written informed consent document. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

1. Severe allergic reaction to any component of PD-1 monoclonal antibodies or other monoclonal antibodies.
2. Active, known or suspected autoimmune disease, including dementia and epilepsy.
3. Has had another known invasive malignancy or unresectable cancer.
4. Coagulation dysfunction: (PT \> 16S, APTT \> 53s, TT \> 21s, FIB \< 1.5g / L), bleeding tendency or thrombolysis, anticoagulation treatment.
5. Severe cardiac disease, lung dysfunction, heart function and lung function lower than grade 3 (≤3).
6. Laboratory abnormality within 7 days before enrollment.
7. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
8. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications before enrollment.
9. Has a known history of Human Immunodeficiency Virus (HIV).
10. Has a known history of Hepatitis B (defined as HBV DNA ≥1000 cps/mL is detected) or known active Hepatitis C virus (defined as: HCV antibody positive) infection.
11. have received anti-tumor herbs within 4 weeks before randomization.
12. Pregnant or nursing women.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: xuekui Liu — Sun Yat-sen University
• Study coordinator: xuekui Liu

Conditions Head and Neck Squamous Cell Carcinoma