Phase 3 Head and Neck Cancer Trial, Recruiting NCT06102395 Sponsor: Beijing Tongren Hospital Condition: Head and Neck Cancer
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Phase 3 Head and Neck Cancer Trial, Recruiting

NCT06102395
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People diagnosed with stage IIIA to IVB head and neck squamous cell carcinoma (a type of head and neck cancer), confirmed by laboratory testing of tissue or cell samples
  • People who have not previously received immunotherapy treatment
  • People the research team believes can safely receive the study drug pembrolizumab combined with chemotherapy or pre-treatment chemotherapy
  • People aged 18 years or older
  • People with a performance status rated 0–2 on the ECOG scale, meaning they are able to carry out at least some daily activities independently (confirm with trial site)
  • People who have measurable areas of cancer that can be tracked during the study using standard imaging guidelines
  • People whose major organs (such as liver, kidneys, and heart) are functioning at an acceptable level
  • People of reproductive potential who agree to use appropriate contraception throughout the study and for 180 days after the last study treatment
  • Male participants who agree not to donate sperm during the study and for 180 days after the last study treatment

Who may not be able to join:

  • People whose cancer has spread to distant parts of the body (distant metastases)
  • Female participants with a positive pregnancy test within 72 hours before starting the study, or within 24 hours of starting radiation therapy
  • People who have received a live vaccine within 30 days before enrolling in the trial
  • People diagnosed with an immune system deficiency, or who have been receiving steroid or other immune-suppressing treatments within 7 days before enrolling
  • People who have cancer that has spread to the brain or the lining around the brain, even if there are no symptoms or it has been treated before
  • People who have had surgery before starting the study and have not fully recovered from its effects or complications
  • People who have previously received an organ or tissue transplant from another person
  • People who have had a severe allergic reaction (grade 3 or higher) to the study drug pembrolizumab, radiation therapy, or certain chemotherapy drugs used in this trial, including platinum, paclitaxel, or 5-FU
  • People who have had an active autoimmune disease (where the immune system attacks the body) requiring ongoing treatment within the past 2 years
  • People with a history of inflammation of the lungs (pneumonia not caused by infection) that required steroid treatment
  • People with a known history of HIV infection
  • People with a history of hepatitis B infection, a positive test for the hepatitis B surface antigen, or active hepatitis C infection
  • People with any other medical history, past treatments, or abnormal test results that the research team believes could affect the study results or the participant's wellbeing
  • People with a known history of mental illness or substance use disorder

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Zhigang Huang, Beijing Tongren Hospital

Phone: +86 13701208337

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Beijing Tongren Hospital
Registry
ClinicalTrials.gov
Start date
1 May 2023
Est. completion
30 April 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Pathological complete response rate (pCR) of pembrolizumab combined with standard chemotherapy neoadjuvant therapy in patients with locally advanced head and neck squamous cell carcinoma; Pathological complete response rate (pCR) of standard chemotherapy neoadjuvant chemotherapy in patients with locally advanced head and neck squamous cell carcinoma

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov