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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Xudong Wang, Dr.
• Email: wxd.1133@163.com
• Phone: +862223340123

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.