Maintenance therapy with Sintilimab after chemoradiotherapy for advanced head and neck cancer

A Prospective Randomized Controlled Study of Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy for Locally Advanced Head And Neck Tumors Based on Peripheral Blood CD8Tex Detection in Peripheral Blood

This study is testing if a new treatment called Sintilimab can help people with advanced head and neck cancer stay healthier after their initial therapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Drugs / interventions: Sintilimab
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06240689 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Sintilimab, an immune checkpoint inhibitor, as a maintenance therapy following chemoradiotherapy in patients with locally advanced head and neck squamous cell carcinoma. Participants will be randomly assigned to receive either Sintilimab or a placebo within one month after completing their initial treatment. The study will monitor participants for safety, side effects, and disease recurrence through regular blood tests and imaging. The goal is to determine if Sintilimab improves outcomes compared to the placebo group.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with inoperable locally advanced head and neck tumors who have undergone concurrent chemoradiotherapy.

Not a fit: Patients with liver metastases or those who do not meet the specified laboratory criteria may 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 advanced head and neck cancer.

How similar studies have performed: Previous studies have shown promise with immune checkpoint inhibitors in similar contexts, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Male or female, age ≥ 18 years old, ≤ 75 years old.
2. Histologically confirmed inoperable locally advanced head and neck tumor T3 or N+ or above.
3. Patients undergoing concurrent chemoradiotherapy
4. ECOG performance status of 0 to 1.
5. Life expectancy of at least 12 weeks.
6. At least one measurable lesion
7. Blood test: absolute neutrophil count (ANC) \> 1.5×109/L, hemoglobin \> 8g/dL and platelet \> 100 ×109/L (subject to the normal value of the clinical trial center).
8. Prothrombin time (PT) \<1.5 times the upper limit of normal and normal thromboplastin time (APTT) \<1.5 times the upper limit of normal.
9. Laboratory examination, serum creatinine less than or equal to 1.5 times the upper limit of the reference range of normal values (If serum creatinine is elevated, 24-hour urine must be collected. Except for the 24-hour creatinine clearance rate is \> 50ml/min).
10. In the absence of liver metastases, ALT or AST is less than or equal to 2.5 times the upper limit of the reference range of normal values, and total serum bilirubin is less than or equal to 1.5 times the upper limit of the reference range of normal values; for patients with liver metastases, ALT or AST is less than or equal to 5 times the upper limit of the reference range of normal values, and total serum bilirubin is less than or equal to 3 times of the upper limit of the reference range of normal values.
11. Females of childbearing potential must be willing to use adequate contraception for the duration of study drug treatment.
12. Signed informed consent.
13. At the end of radiotherapy, the proportion of PD1+CD8T cells in peripheral blood is greater than 10%, or more than 2 times higher than baseline

Exclusion Criteria:

1. Active autoimmune disease requiring systemic therapy (i.e., use of disease-modifying medications, corticosteroids, or immunosuppressants) within the previous 2 years. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic treatments.
2. Diagnosed with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial therapy. After consultation with the sponsor, the use of physiologic doses of corticosteroids may be approved.
3. Other malignancies that are known to be progressing or requiring active treatment. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has received curative therapy are excluded.
4. Have an active infection requiring systemic therapy.
5. Medical history or evidence of disease that may confound the results of the trial, prevent the subject from participating in the study throughout the study, abnormal treatment or laboratory values, or the investigator believes that participation in the study is not in the best interest of the subject.
6. Known psychiatric or substance abuse disorder that may affect compliance with test requirements.
7. Female subjects who are pregnant or lactating, or who are expected to conceive during the planned trial period or up to 180 days after the last dose of study treatment, or male subjects whose spouse is preparing to become pregnant.
8. Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) infection.

Where this trial is running

Hangzhou, Zhejiang

• The Second Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Ting Zhang, prof.

Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma