Combining radiotherapy with Tislelizumab for recurrent head and neck cancer

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

This study is testing if combining a type of radiation therapy with the drug Tislelizumab can help people with recurrent head and neck cancer feel better and improve their health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: Chemotherapy, Immunotherapy, radiation, Tislelizumab
• Locations: 2 sites (Chengdu, Sichuan and 1 other locations)
• Trial ID: NCT05595590 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of pulsed radiotherapy administered alongside Tislelizumab in patients with locoregionally recurrent head and neck squamous cell carcinoma (HNSCC). Participants will receive this combination treatment to assess its impact on tumor burden and overall health outcomes. The study will include patients who have previously undergone radical therapy and have measurable tumor lesions. The approach seeks to enhance treatment efficacy through the synergistic effects of immunotherapy and radiotherapy.

Who should consider this trial

Good fit: Ideal candidates are individuals with confirmed squamous cell head and neck cancer who have previously received radical therapy and have a Karnofsky performance status of 70 or higher.

Not a fit: Patients who are pregnant, breastfeeding, or planning to become pregnant during the study period will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with recurrent head and neck cancer.

How similar studies have performed: While this specific combination of treatments is being explored, similar approaches using immunotherapy and radiotherapy have shown promise in other studies.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan and 1 other locations

• Sichuan Cancer Hosiptal — Chengdu, Sichuan, China (Recruiting)
• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Principal investigator: Ximei Zhang, Dr. — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Ximei Zhang, Dr.

Conditions Head and Neck Cancer