Investigating immune therapy for advanced head and neck cancer after initial treatment

A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy

This study is testing a new immune therapy combined with radiation and chemotherapy to see if it can help people with advanced head and neck cancer who have responded well to initial treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 268 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06208826 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of immune maintenance therapy in patients with locally advanced head and neck squamous cell carcinoma who have achieved major pathological response (MPR) after receiving neoadjuvant immunotherapy combined with chemotherapy. The study will involve administering Toripalimab, radiation therapy, and Cisplatin to assess their impact on patient outcomes. The trial is designed to address the significant clinical need for improved treatment options in this patient population, given the low survival rates associated with standard treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with locally advanced head and neck squamous cell carcinoma who have achieved MPR after neoadjuvant therapy.

Not a fit: Patients with metastatic or unresectable head and neck cancer, or those with active autoimmune diseases, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option that improves survival rates for patients with advanced head and neck cancer.

How similar studies have performed: Other studies have shown promising results with immunotherapy in similar contexts, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Able to understand and willing to give an informed consent for the study.
* Males or females aged 18 to 80 years.
* Have an Eastern Co-operative Oncology Group (ECOG) performance status less than equal to 1.
* Pathologically (histologically or cytologically) confirmed, non-metastatic diagnosis of squamous cell carcinoma of head and neck (SCCHN).
* Achievement of major pathological reaponse (MPR) after surgery with neoadjuvant immunotherapy combined chemotherapy.
* Adequate bone marrow, liver, and renal function:

Absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 9.0g/dL, platelets ≥100000/μL; ALT and AST \< 2.5× upper limit of normal (ULN), total bilirubin ≤ 1.5×ULN； Creatinine clearance ≥ 60 ml/min； APTT≤ 1.5×ULN.

Exclusion Criteria:

* Participant has metastatic/unresectable SCCHN.
* Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
* With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
* With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
* With active infection requiring systemic therapy.
* Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
* Any other factors that are not suitable for inclusion in this study judged by investigators.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xudong Wang, Dr.

Conditions Head and Neck Cancer