Radiotherapy With Tislelizumab in Patients With Recurrent Head & Neck Cancer

Phase II Trial of Pulsed Radiotherapy Combined With Tislelizumab in Patients With Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma

The purpose of this study is to determine the efficacy and safety of pulsed radiotherapy given concomitantly with Tislelizumab and as maintenance therapy in participants with locoregionally recurrent head and neck squamous cell carcinoma ( HNSCC).

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: Tislelizumab; Radiation: Pulse radiation

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ximei Zhang, Dr.; Phone Number: +86-22-23340123; Email: xiangrikuigirl@126.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Sichuan Cancer Hosiptal
      • Contact: Peng Zhang, Dr.; Phone Number: +86-28-85420897
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Ximei Zhang, Dr.; Phone Number: +86-22-23340123

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Confirmed squamous cell head and neck cancer, A karnofsky performance status≥70.
• Previous radical therapy (surgery ± chemoradiotherapy or radical chemoradiotherapy) and the records of radiation fields and dosage of previous treatment can be obtained.
• Inoperable or completely resectable under MDT consultation.
• Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan or magnetic resonance imaging, based on RECIST version 1.1
• Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
• Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy

Exclusion Criteria:

• Pregnant or breastfeeding, or planning to become pregnant during the study period
• The patient had another malignant tumor expcet HNSCC
• Have an active autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, test positive for HIV or have a history of any of these diseases, or have a history of organ transplantation;
• They had received reradiotherapy within 1 month prior to entering the study
• Receiving systemic immunosuppressive drugs within 2 weeks prior to commencing study treatment, or anticipating needing systemic immunosuppressive drugs during study treatment;
• having received systemic immune-stimulating agents (including but not limited to interferon or interleukin-2 [IL-2]) within 4 weeks prior to study treatment initiation or remaining within 5 half-lives (whichever is longer);
• A history of other malignancies within the past 5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, and ductal carcinoma in situ;
• Severe cardiovascular disease (e.g., New York College of Cardiology heart disease class Ⅱ or greater, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina within 3 months before commences study treatment;
• The subject has an active infection or infectious disease, or develops a fever of unknown origin (body temperature >38.5 ° C) during screening and before the first dose;
• had received therapeutic oral or intravenous antibiotics within 2 weeks prior to starting the study; Patients receiving prophylactic antibiotic therapy, such as prevention of urinary tract infection or chronic obstructive pulmonary disease, were enrolled.
• Untreated active hepatitis (hepatitis B: HBsAg positive with abnormal liver function and HBV-DNA≥104ml; Hepatitis C: HCV-RNA≥103/ml or antiviral therapy required during the study);
• Immunotherapy such as PD-1/L1 antibody or CTLA-4 antibody within 4 weeks before enrollment.
• Chemotherapy or targeted therapy within 4 weeks prior to enrollment;
• Subjects have participated in or completed other clinical trials within 4 weeks prior to enrollment;
• Subjects may need to receive other antitumor treatments during the study;
• Subjects may need to have been vaccinated during the study or within 4 weeks prior to enrollment.
• A patient who, in the investigator's judgment, has other comorbidities that seriously jeopardize the patient's safety or interfere with the patient's completion of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab + Pulse radiation; Participants receive pulsed radiationtherapy concurrent with 3 cycles of Tislelizumab followed by an additional 32 cycles of Tislelizumab alone as maintenance therapy.	Drug: Tislelizumab; Administered as an intravenous (IV) infusion 200mg every 3 weeks (Q3W); Radiation: Pulse radiation; 66-70Gy/33-35Fx, 2Gy/Fx.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR) using iRECIST 1.1 criteria	ORR is defined as the proportion of patients who achieved a best response of complete response (CR) or partial response (PR) using iRECIST 1.1 criteria, and will be evaluated for both the lesion(s) treated with RT, referred to as "Target lesion (RT+ Tisle), as well as the lesion(s) not treated with RT (if applicable), referred to as "Target lesion (Tisle only)", per the prescribed treatment.	From time of first dose of study treatment until disease progression or death (up to 2 years)
Adverse Events (AEs)	Number of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.	From time of first dose of study treatment until the end of follow-up (up to 2 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR)	The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.	From time of first dose of study treatment until disease progression or death (up to 2 years)
Progression Free Survival (PFS)	PFS is the average length of time after the start of treatment in which a person is alive, and their cancer does not grow or spread. PFS is defined as the time from day 1 of treatment until the criteria for disease progression is met as defined by RECIST1.1 or death as a result of any cause.	From time of first dose of study treatment until disease progression or death (up to 2 years)
Change From Baseline Quality of Life (GHS/QoL)	Change from baseline in QoL using the European Organization for Research and Treatment of Cancer Head and Neck Questionnaire (EORTC QLQ-H&N35)	From time of first dose of study treatment until disease progression or death (up to 2 years)

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Principal Investigator: Ximei Zhang, Dr., Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 20, 2022
• Primary Completion (Anticipated): October 19, 2024
• Study Completion (Anticipated): October 19, 2026

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: E20220816

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