Watch-and-Wait After Immunochemotherapy in Locally Recurrent Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICI-chemotherapy and LIMT.
- Who it may be relevant to
- Registry conditions: Recurrent Nasopharyngeal Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Watch-and-Wait Strategy in Patients With Objective Response After Immuno-chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma: A Prospective Multicenter Observational Study
Overview
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.
Interventions
- Drug ICI-chemotherapy and LIMT
gemcitabine, docetaxel, paclitaxel, cisplatin, platinum, capecitabine, S1; Tislelizumab.
Primary outcome measures
- 2-year progression-free survival [Time frame: Counting from the start of the treatment for two years.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07088484 · lrNPCimmuno