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New treatment option for Head and Neck Cancer
Official title Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC
ClinicalTrials.gov ID: NCT06345287
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
- The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients.
- 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
- Head and neck squamous cell carcinoma patients who undergo 2-4 cycles of induction chemotherapy and immunotherapy and plan to undergo radical...
- Age range from 18 to 75 years old;
- Squamous cell carcinoma of the head and neck confirmed by pathological tissue biopsy;
- Clinical staging is T1-2N2-3M0, T3-4N0-3M0 (AJCC 8th edition);
- HPV or P16 (-);
You likely can't join if
- Previous or concurrent incurable malignant tumors in other parts, except cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid...
- Suffering from any active autoimmune disease or having a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis...
- Suffering from uncontrolled cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias...
- Active infection or unexplained fever exceeding 38.5 ℃ during screening or before first administration (according to the researcher's judgment...
- People with congenital or acquired immune deficiency (such as HIV infected people), active hepatitis B (HBV-DNA ≥ 104 copies/ml) or hepatitis C...
- Previously received other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1;
See the full eligibility criteria
- Head and neck squamous cell carcinoma patients who undergo 2-4 cycles of induction chemotherapy and immunotherapy and plan to undergo radical radiotherapy treatment ( after MDT evaluation and communication with the...
- Age range from 18 to 75 years old;
- Squamous cell carcinoma of the head and neck confirmed by pathological tissue biopsy;
- Clinical staging is T1-2N2-3M0, T3-4N0-3M0 (AJCC 8th edition);
- HPV or P16 (-);
- ECOG score 0-1 points;
- No contraindications to immunotherapy and radiotherapy;
- The functional level of the main organs meets the following standards:1) The blood routine examination standards need to meet: WBC ≥ 3.0 × 109/L, ANC ≥ 2.0 × 109/L, PLT ≥ 100 × 109/L, HGB ≥ 90g/L (no blood transfusion...
- Women of childbearing age must have taken reliable contraceptive measures, or have undergone pregnancy tests (serum or urine) within 7 days before enrollment, and the results are negative. They must be willing to use...
- Voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.
- Previous or concurrent incurable malignant tumors in other parts, except cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma and superficial bladder cancer;
- Suffering from any active autoimmune disease or having a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis...
- Suffering from uncontrolled cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥ 470 ms); According to NYHA standards, patients...
- Active infection or unexplained fever exceeding 38.5 ℃ during screening or before first administration (according to the researcher's judgment, people with fever caused by tumors can be included in the study);
- People with congenital or acquired immune deficiency (such as HIV infected people), active hepatitis B (HBV-DNA ≥ 104 copies/ml) or hepatitis C (hepatitis C antibody is positive, and HCR-RNA is higher than the detection...
- Previously received other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1;
- Known to be allergic to cisplatin, macromolecular protein preparations, or any anti PD-1 antibody component;
- If the subject undergoes major surgery without tumor treatment, the toxic reactions and/or complications caused by the surgical intervention must be fully recovered before starting treatment;
- Pregnant or lactating women;
- In the investigator's judgment, the people had other factors that might have led to their forced discontinuation of the study, such as other serious medical conditions (including mental illness) requiring concomitant...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 Beijing, 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.