Phase 2 Head and Neck Cancer Trial, Recruiting NCT06323239 Sponsor: Sun Yat-sen University Condition: Head and Neck Cancer
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Phase 2 Head and Neck Cancer Trial, Recruiting

NCT06323239
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:

  • People who have been diagnosed with recurrent or metastatic nasopharyngeal carcinoma (cancer of the back of the nose/throat that has come back or spread)
  • People whose cancer has been confirmed by a tissue sample as a specific type of nasopharyngeal carcinoma (WHO Type II or III)
  • People who have a good general level of physical functioning, able to carry out normal daily activities with little or no limitation (ECOG score of 0 or 1)
  • People who have not yet received any treatment — such as radiotherapy, chemotherapy, immunotherapy, or biological therapy — for their recurrent or metastatic nasopharyngeal carcinoma
  • People who have no medical reasons preventing them from receiving immunotherapy or chemoradiotherapy
  • People who have at least one tumour that doctors determine can safely be treated with a focused type of radiation called SBRT
  • People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1)
  • People whose blood counts are within an acceptable range, indicating the bone marrow is functioning adequately (confirm with trial site for specific values)
  • People whose liver function test results are within acceptable limits (confirm with trial site for specific values)
  • People whose kidney function results are within acceptable limits (confirm with trial site for specific values)
  • People who agree to use effective contraception during treatment and for three months after treatment ends
  • People who have been fully informed about the nature of the study and have signed a written consent form

Who may not be able to join:

  • People with a known allergy to monoclonal antibodies, any component of PD-1 antibody medicines, or the chemotherapy drugs gemcitabine or cisplatin
  • People who have an unexplained fever above 38.5°C that is not related to the tumour itself
  • People who have an active autoimmune disease — a condition where the immune system attacks the body's own tissues (for example, certain eye, gut, liver, kidney, thyroid, or blood vessel conditions, or asthma requiring specific inhaler treatment)
  • People with a known history of HIV, active Hepatitis B, or positive Hepatitis C antibody results
  • People with significant heart problems, including severe heart failure (NYHA class 3 or 4), unstable chest pain, a heart attack within the past year, or a serious irregular heartbeat requiring treatment
  • People who are pregnant or breastfeeding
  • People who have had another cancer in the past, except for certain treated skin cancers, early-stage cervical cancer, or a specific low-risk type of thyroid cancer
  • People who have received a live vaccine within 30 days before the planned start of the study
  • People with a psychiatric condition or substance use disorder that could interfere with their ability to take part in the study
  • People with any other condition — including mental health concerns or personal/social circumstances — that, in the doctor's judgement, could affect the person's ability to participate or affect the reliability of the study results

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 14 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

Principal Investigator: Chong Zhao, MD. PhD., Sun Yat-sen University

Phone: 13631355201

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
Registry
ClinicalTrials.gov
Start date
15 July 2024
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Progression-free survival

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: 14 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