Phase 3 Head and Neck Cancer Trial, Recruiting NCT06177301 Sponsor: Fudan University Condition: Head and Neck Cancer
Back to Head And Neck Cancer

Phase 3 Head and Neck Cancer Trial, Recruiting

NCT06177301
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:

  • Your nasopharyngeal carcinoma (a type of head and neck cancer) has come back or spread, confirmed by a tissue or cell test
  • You have not previously received systemic (whole-body) treatment for the recurrent or spread cancer — though if you had chemotherapy before, you may still qualify if it ended at least 6 months ago
  • You are between 18 and 75 years old (male or female)
  • You are generally well enough to carry out light activity and care for yourself (a doctor will assess this)
  • You have at least one tumour that can be measured on a scan, meeting specific size requirements (confirm with trial site)
  • Your blood counts are within acceptable levels, including red blood cells, white blood cells, and platelets (confirmed by a blood test)
  • Your liver and kidney function test results are within acceptable ranges (confirmed by blood tests)
  • Your blood clotting results are within acceptable ranges
  • If you could become pregnant, you agree to use contraception and have had a negative pregnancy test within 2 weeks before joining
  • You are willing to provide a small sample of tumour tissue (such as stored tissue slides or a wax block)
  • You are expected to live for at least 3 more months
  • You are willing to take part and have signed a consent form

Who may not be able to join:

  • Your cancer has come back in one area only and could be treated with surgery or radiotherapy
  • You have had a serious allergic reaction to monoclonal antibody treatments in the past
  • You have previously been treated with certain immunotherapy drugs (PD-1, PD-L1, or CTLA-4 antibodies)
  • You have significant heart problems, such as severe heart failure, unstable chest pain, a heart attack within the last 6 months, or certain abnormal heart rhythms
  • You have an autoimmune disease requiring treatment, or have used steroids or immune-suppressing medicines long-term for conditions such as thyroid problems, lung inflammation, or colitis
  • You have uncontrolled diabetes or certain serious lung conditions
  • You have active hepatitis B, hepatitis C, HIV, or another condition that weakens your immune system
  • You currently have a severe active infection
  • Your cancer has spread to the brain and is causing symptoms
  • You have had another type of cancer in the past, unless you were fully cured more than 5 years ago
  • You have a serious neurological or psychiatric condition, such as dementia or epilepsy
  • You have a history of drug misuse or other personal circumstances that could affect your participation in the study
  • The trial doctors have another reason they feel you are not suitable (confirm with trial site)

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 12 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: Dongmei Ji, M.D, Fudan University

Phone: 021-64175590

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
Registry
ClinicalTrials.gov
Start date
1 December 2023
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

To compare the progression-free survival of tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the ITT analysis set evaluated by the researchers according to RECIST v1.1.

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: 12 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