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NCT Number: NCT07088484

Watch-and-Wait After Immunochemotherapy in Locally Recurrent Nasopharyngeal Carcinoma

The purpose of this study is to compare chemotherapy plus immunotherapy with immunochemotherapy combined subsequent locoregional radiotherapy in recurrent nasopharyngeal carcinoma (NPC), in order to confirm the value of immunotherapy and chemotherapy in recurrent NPC patients.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years, regardless of sex.
  • Treatment-naïve patients with newly diagnosed metastatic nasopharyngeal carcinoma (NPC).
  • Receiving immunotherapy. (or Treated with immunotherapy)
  • At least one measurable tumor lesion according to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1.
  • Adequate organ function.
  • Signed and dated informed consent form indicating that the patient (or legally authorized representative) has been informed of all pertinent aspects of the study.
  • Patients willing and able to comply with scheduled visits and study procedures.

Exclusion criteria

  • Patients with distant metastasis of nasopharyngeal carcinoma.
  • Patients who have not received immunotherapy or chemotherapy. (Alternatively: No prior immunotherapy or chemotherapy.)
  • History of another active malignancy within the past 5 years, except for malignancies with a negligible risk of metastasis or death (e.g., expected 5-year overall survival >90%) or malignancies treated with curative intent and with no evidence of disease (e.g., adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, localized prostate cancer treated with curative intent, ductal carcinoma in situ of the breast treated surgically with curative intent).
  • Lack of capacity to provide informed consent.

Treatment and study plan

ICI-chemotherapy and LIMT

Drug

gemcitabine, docetaxel, paclitaxel, cisplatin, platinum, capecitabine, S1; Tislelizumab.

Primary outcomes

  1. 2-year progression-free survival

    Time frame: Counting from the start of the treatment for two years.

    Defined as the time from the initiation of ICI-chemotherapy to disease progression or death for any reason, whichever occurred first.

Study contacts

Contact information is provided by the study sponsor or research team.

qiaojuan Guo

CONTACT

[email protected]

15080013157

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Registry information

Official study title

Watch-and-Wait Strategy in Patients With Objective Response After Immuno-chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma: A Prospective Multicenter Observational Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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