Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT06486220
Eligibility Criteria:
Inclusion Criteria:
1. 18-60 years old;
2. Pathological diagnosis of nasopharyngeal carcinoma;
3. Patients diagnosed with oligometastatic nasopharyngeal carcinoma who meet stage IVb as defined by the International Union against Cancer and the American Joint Committee on Cancer (UICC/AJCC) staging System (8th edition) (Oligometastatic as ≤3 organs and ≤5 sites of metastasis);
4. Patients with metastatic nasopharyngeal carcinoma who had not previously received systematic chemotherapy for the disease in this study, except neoadjuvant chemotherapy, concurrent chemoradiotherapy or adjuvant chemotherapy received 6 months before the first administration;
5. Karnofsky's functional status score should be at least 70 points (if the functional status score is decreased due to tumor, it should be appropriately relaxed after the researchers' judgment, and the minimum score should be no less than 50 points, as shown in Annex I);
6. According to the RECIST1.1 evaluation criteria, there should be at least 1 measurable lesion, and the measurable lesion should not have received local treatment such as radiotherapy;
7. Expected survival ≥3 months;
8. A tolenrant organs.
Exclusion Criteria:
1. allergy to 5-FU, gemcitabine, cisplatin, other monoclonal antibodies, or any component of triplimab
2. Prior treatment with PD-1 receptor or its ligand PD-L1 or cytotoxic T lymphocyte-associated protein 4 (CTLA4) receptor;
3. Had major surgery other than diagnosis of nasopharyngeal cancer within 28 days prior to randomization or was expected to require major surgery during the study period;
4. Patients with severe damage of intestinal barrier such as sepsis, active massive bleeding of digestive tract and perforation due to various reasons;
5. Currently diagnosed with fulminant colitis or toxic megacolon;
6. Enteral nutrition patients who cannot tolerate 50% of heat calorie requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula, etc.;
7. patients with any active autoimmune disease or a history of autoimmune diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06486220
Study Brief:
Protocol Section:
NCT06486220