Clinical trial NCT06208826: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Disease Free Survival
timeFrame: up to 4 years
Secondary outcomes:
measure: Over survival (OS)
timeFrame: up to 4 years
measure: Toxicity Adverse events
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: