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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.