BridgeMD
New treatment option for Head and Neck Cancer
Official title Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy
ClinicalTrials.gov ID: NCT05777824
What this study is testing
What is anti-PD-1 or PD-L1 antibody?
anti-PD-1 or PD-L1 antibody is an investigational medicine, being studied as a potential treatment for head and neck cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The people 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;
You likely can't join if
- Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
- Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy;
- Previously experienced head and neck radiation therapy;
- people who have used corticosteroids (\>10 mg/day prednisone or other equivalent hormones) or other immunosuppressive agents for systemic treatment...
- Patients with pleural effusion, pericardial effusion or ascites that need to be drained with clinical symptoms, or who have received serous cavity...
- Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled...
See the full eligibility criteria
- The people 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;
- Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
- Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy;
- Previously experienced head and neck radiation therapy;
- people 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...
- 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...
- Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
The study team makes the final eligibility decision.
Where it's taking place
- Beijin, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijin, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.