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NCT05777824RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 11 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
84 (estimated)
First submitted
7 Mar 2023
Start date
1 Jan 2023
Primary completion date
30 Dec 2025
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
NCT number
NCT05777824

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 84
  • From 1 Jan 2023 to the primary completion date, 30 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy;
  • Previously experienced head and neck radiation therapy;
  • Subjects who have used corticosteroids (\>10 mg/day prednisone or other equivalent hormones) or other immunosuppressive agents for systemic treatment within 1 month before enrollment. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy at therapeutic doses of prednisone ≤10 mg/day are permitted;
  • Patients with pleural effusion, pericardial effusion or ascites that need to be drained with clinical symptoms, or who have received serous cavity effusion drainage for the purpose of treatment within 2 weeks before enrollment;

Other illness

  • Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
  • Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes

Who the study is looking for

  • The subjects are not limited by gender, age from 18 to 75 years old;
  • Histopathologically confirmed squamous cell carcinoma of the head and neck cancer;
  • Locally advanced squamous cell carcinoma diagnosed as T3-4 or N+ stage according to AJCC 8th edition staging;
  • ECOG score 0-1;
  • without distant metastasis;
  • received induction chemotherapy plus immunotherapy, followed by surgery
  • The expected survival is expected to be no less than 6 months.
  • No contraindications to chemotherapy, immunotherapy, and radiotherapy;

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
Coordinator of this site? Confirm its status
BeijinChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.