KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and … (NCT05294172) | Clinical Trial Compass
Active — Not RecruitingPhase 3
KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
China295 participantsStarted 2022-06-07
Plain-language summary
The study is to evaluate the efficacy of KL-A167 combined with cisplatin and gemcitabine vs placebo combined with cisplatin and gemcitabine in the treatment of recurrent or metastatic nasopharyngeal carcinoma, as measured by progression-free survival (PFS) per the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* The ages at the time of signing the informed consent are ≥ 18 years old and ≤ 75 years old, regardless of gender.
* Patients with nasopharyngeal carcinoma diagnosed definitively by histology or cytology.
* Recurrent or metastatic nasopharyngeal carcinoma:Nasopharyngeal carcinoma patients with distant metastasis at the time of initial diagnosis (stage IVB nasopharyngeal carcinoma as defined by the 8th Edition of the staging system of Union for International Cancer Control and American Cancer Joint Committee); or nasopharyngeal carcinoma patients with local recurrence and/or distant metastasis more than 6 months after the end of previous radical treatment.Have not received systematic treatment for recurrent or metastatic nasopharyngeal carcinoma before; those who have local recurrence are not suitable for local treatment or have been treated locally.
* Eastern Cooperative Oncology Group (ECOG) performance status is 0 \~ 1 score, and the expected survival time is ≥ 12 weeks.
* At least one measurable lesion according to RECIST 1.1; the lesions that have received radiotherapy are not selected as target lesions.
* Patients must provide tissues or tissue specimens for biomarker analysis during the screening period, and the freshly obtained tissues are preferred. Patients who cannot obtain the fresh tissues can provide archived paraffin sections.
* Significant organ functions meet the following requirements:a)Blood routine: Neutrophil count (NEUT) ≥ 1.5×109/L;…