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 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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Radiation: Radiation Therapy; Drug: Cisplatin; Drug: Toripalimab

• Study Type: Interventional
• Enrollment (Estimated): 268
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xudong Wang, Dr.; Phone Number: 3130 +862223340123; Email: wxd.1133@163.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300000
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Xudong Wang; Phone Number: +862223340123; Email: wxd.1133@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Toripalimab; toripalimab, IV, 240mg, q3w, for 15 cycles	Drug: Toripalimab; Toripamab, IV, 240mg, every 3 weeks for 15 cycles
Active Comparator: SOC CCRT or radiotherapy; Standard concurrent radiochemotherapy or postoperative radiotherapy	Radiation: Radiation Therapy; Radiation Therapy; Drug: Cisplatin; Chemotherapy agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Toxicity Adverse events	Grade 1-5 AEs according to NCI-CTCAE V5.0	up to 1 year

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: January 7, 2024
• First Submitted That Met QC Criteria: January 7, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Therapeutics; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Cisplatin; Radiotherapy; toripalimab
• Other Study ID Numbers: FERRY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No