About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
All included patients will undergo protocolized ICI-chemotherapy for 4-6 cycles, following by LIMT, with the local treatment be postponed or omitted.
Trial design
Cohort
Prospective
Treatments tested in this trial
ICI-chemotherapy and LIMT
Druggemcitabine, docetaxel, paclitaxel, cisplatin, platinum, capecitabine, S1; Tislelizumab.
Treatment groups
Trial outcomes
Primary outcomes
2-year progression-free survival
Defined as the time from the initiation of ICI-chemotherapy to disease progression or death for any reason, whichever occurred first.
Locations
Sponsors and contacts
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