NCT06208826RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 3 Mar 2026

Brief summary (registry, in English)

Head and neck cancer is the malignant tumor with the highest morbidity and mortality, of which 60% present with locally advanced disease at initial diagnosis, and the 5-year survival rate of standard treatment is less than 30%. Standard of care (SOC) including adjuvant and neoadjuvant therapy can provides only about 5-10% clinical benefit. According to the available data on the application of immunotherapy as adjuvant therapy in operable patients, adjuvant immunotherapy is safe and feasible, with a significant trend of benefit. Based on the above positive and meaningful clinical needs and scientific basis, it is very necessary to carry out clinical trials of adjuvant immunotherapy. The primary objective of this study is to evaluate the efficacy and safety of immune maintenance therapy in patients with locally advanced head and neck squamous cell carcinoma who achieve MPR after neoadjuvant immunotherapy combined with chemotherapy.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 268 (estimated)
First submitted: 7 Jan 2024
Start date: 1 Sept 2023
Primary completion date: 1 Sept 2027
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Diseases: Head and neck cancer
NCT number: NCT06208826

What you commit to

Study type: Interventional · Phase 2
Planned participants: 268
From 1 Sept 2023 to the primary completion date, 1 Sept 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.

Other illness

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.

Other

Participant has metastatic/unresectable SCCHN.
Any other factors that are not suitable for inclusion in this study judged by investigators.

Who the study is looking for

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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status	Tianjin	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.