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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Second Affiliated Hospital of Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Ting Zhang, prof.
• Email: zezht@zju.edu.cn
• Phone: +8615157125533

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sintilimab Plus Hypofractionated Radiotherapy Then Chemoradiotherapy for Locally Advanced Head and Neck Cancer

  This study tests whether giving sintilimab with a short, high-dose radiotherapy course followed by standard chemoradiotherapy helps people with locally advanced head and neck squamous cell carcinoma.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07781072

• Omitting Postoperative Cervical Radiation in Select Head and Neck Cancer Patients

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• Becotatug vedotin plus PD-1 inhibitor versus PD-1 inhibitor alone for EGFR‑positive resectable locally advanced head and neck cancer

  This trial will test if adding becotatug vedotin to a PD‑1 blocker given before and after surgery helps people with EGFR‑positive, CPS≥1 resectable locally advanced head and neck cancer do better than a PD‑1 blocker alone.

  Recruiting Phase 3 Sun Yat-sen University · Zhuhai, Guangdong · NCT07524452

• Low-dose radiotherapy plus anti–PD-1 immunotherapy before surgery for resectable locally advanced head and neck cancer

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  Recruiting Phase 2 Fifth Affiliated Hospital, Sun Yat-Sen University · Guangdong · NCT07371234

• Comparing smaller, targeted surgery versus standard surgery after pre-surgery immunotherapy for locally advanced head and neck cancer

  This trial tests whether smaller, response-guided surgery instead of the usual larger operation after neoadjuvant PD-1‑based chemoimmunotherapy works for people with resectable locally advanced head and neck squamous cell carcinoma who had a partial or complete response.

  Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07369882

• MRG003 alone or with the PD‑1 drug pucotenlimab before chemoradiotherapy for locally advanced head and neck squamous cell carcinoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.