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Trial 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
NCT ID:
NCT06208826
Condition:
Head and Neck Cancer
Conditions: Official terms:
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Cisplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Toripamab, IV, 240mg, every 3 weeks for 15 cycles
Arm group label:
Toripalimab
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
Radiation Therapy
Arm group label:
SOC CCRT or radiotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Chemotherapy agent
Arm group label:
SOC CCRT or radiotherapy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xudong Zhu
Phone:
+862223340123
Email:
wxd.1133@163.com
Start date:
September 1, 2023
Completion date:
September 1, 2028
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06208826
