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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208826
• Other study ID #: FERRY
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2023
• Est. completion date: September 1, 2028

Study information

• Verified date: January 2024
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Xudong Zhu, Dr.
• Phone: +862223340123
• Email: wxd.1133[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: September 1, 2028
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Toripalimab
Toripamab, IV, 240mg, every 3 weeks for 15 cycles

Radiation:
• Radiation Therapy
Radiation Therapy

Drug:
• Cisplatin
Chemotherapy agent

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival	defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.	up to 4 years
Secondary	Over survival (OS)	OS is defined as the time from randomization to death due to any cause or censored at the date of last follow-up.	up to 4 years
Secondary	Toxicity Adverse events	Grade 1-5 AEs according to NCI-CTCAE V5.0	up to 1 year