RecruitingPhase 2NCT05777824

Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy

Pathological Response Adapted Decision-making of Postoperative Management for HNSCC Receiving Induction Immunotherapy and Chemotherapy


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

84 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To develop postoperative stratification treatment for patients who have received induction chemotherapy and immunotherapy in locally advanced head and neck cancers. Risk stratification is based on clinical characteristics and pathological responses. In order to achieve no inferior survival rate and a lower treatment-related toxicity rate than the standard treatment.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how to manage treatment after surgery for people with locally advanced head and neck squamous cell carcinoma (a type of cancer in the mouth, throat, or neck). Participants first receive chemotherapy combined with immunotherapy before surgery. After surgery, the treatment plan is tailored based on how well the cancer responded. The goal is to improve outcomes while reducing unnecessary treatment. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with squamous cell carcinoma of the head and neck confirmed by biopsy - Your cancer is locally advanced (stage T3-T4 or has spread to lymph nodes) but has not spread to distant organs - You have already received induction chemotherapy plus immunotherapy, followed by surgery - Your general health is good (ECOG score 0–1) and you are expected to survive at least 6 months **You may NOT be eligible if:** - You have a history of other cancers (except early-stage skin cancer or cervical carcinoma in situ) - You received other anti-cancer treatments for this cancer before the induction therapy - You have had previous radiation to the head or neck - You are on high-dose corticosteroids or immunosuppressants - You have serious heart, brain, or other major health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTanti-PD-1 or PD-L1 antibody

immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy

RADIATIONpostoperative radiaotherapy

postoperative radiotherapy (60Gy or 50Gy)


Locations(1)

National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC

Beijin, Beijing Municipality, China

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NCT05777824


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