Phase 2 Head and Neck Cancer Trial, Recruiting NCT05343325 Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University Condition: Head and Neck Cancer
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Phase 2 Head and Neck Cancer Trial, Recruiting

NCT05343325
Recruiting Phase 2

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:

  • You have been diagnosed with a specific type of cancer called squamous cell carcinoma in the head and neck area (mouth, throat, voice box, or lower throat), confirmed by a tissue sample, that has not yet been treated and is at a certain stage of severity.
  • Surgeons have determined that your cancer can be treated with surgery aimed at fully removing it.
  • You are between 18 and 70 years old.
  • You are generally able to carry out daily activities with no more than mild limitations (confirm with trial site).
  • You are expected to live for more than 6 months.
  • You have at least one area of cancer that can be measured on a scan.
  • Your blood, liver, and kidney test results are within acceptable ranges, without having received blood products or certain growth-stimulating medicines in the 14 days before testing (confirm with trial site for specific values).
  • Your thyroid hormone levels are within an acceptable range, or if slightly abnormal, certain related hormone levels are still normal.
  • Women who could become pregnant must agree to use contraception during treatment and for 3 months after.
  • You are willing to voluntarily join the study and sign a consent form, and are able to follow the study requirements.

Who may not be able to join:

  • Women who are pregnant or currently breastfeeding.
  • People who have a known allergy to any of the study medicines (a type of immunotherapy called a PD-1 inhibitor, or the chemotherapy drugs albumin-bound paclitaxel or cisplatin).
  • People who have had another type of cancer in the past 5 years or currently, with exceptions for certain fully cured skin cancers, a very early form of cervical cancer, or a specific type of benign thyroid growth.
  • People with serious heart problems that are not under control, such as significant heart failure, unstable chest pain, a heart attack within the past year, or certain serious heart rhythm problems requiring treatment.
  • People who have taken an experimental drug before joining, or who are already participating in another active clinical treatment trial.
  • People who needed high-dose steroid medicines or other immune-suppressing medicines in the 2 weeks before starting the study (with some exceptions — confirm with trial site).
  • People who received a live vaccine within 4 weeks before starting the study.
  • People who had major surgery or a serious injury within 4 weeks before starting the study.
  • People who had a serious infection requiring a hospital stay within 4 weeks before starting the study, or signs of an active lung infection or other infection requiring antibiotic treatment within 2 weeks before starting.
  • People with a history of active autoimmune diseases (conditions where the immune system attacks the body), such as certain lung, gut, liver, or kidney conditions, though some mild conditions like vitiligo may not automatically exclude you (confirm with trial site).
  • People with a weakened immune system, including those who are HIV-positive, or who have had an organ or bone marrow transplant.
  • People with active tuberculosis (TB), or a history of TB within the past year, or a history of TB that was never properly treated.
  • People with active hepatitis B or hepatitis C infection at certain levels detected in blood tests.
  • People with a known history of substance abuse, alcohol dependency, or drug misuse.
  • People who the research team determines are not suitable for the trial for other medical reasons.

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 20 July 2026
Phase 2: approximately ~30% 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

Phone: 07562526192

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 2
Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
Registry
ClinicalTrials.gov
Start date
9 March 2022
Est. completion
31 March 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Pathological complete response (pCR) rate

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: 20 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