Maintenance Therapy With Treprilimumab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma, Maintenance Therapy
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
Eligibility Criteria
Inclusion Criteria: The age at the time of diagnosis is 18-75 years old, regardless of gender; Histologically confirmed nasopharyngeal carcinoma; Confirm the presence of distant metastasis in advanced nasopharyngeal carcinoma patients or recurrent nasopharyngeal carcinoma patients who cannot receive local treatment. ; After receiving standard treatment for 4-6 cycles, the disease is control; ECOG score 0-1; Expected survival time of at least 12 weeks; Patients who have not received systemic chemotherapy within 6 months prior to diagnosis ; According to RECIST 1.1 standard, at least 1 measurable lesion; Enough organ function; Sign an informed consent form; Female participants with fertility and male participants with fertility partners must agree to use reliable contraceptive measures within 6 months after screening and the last treatment. Exclusion Criteria: Patients who are known to be intolerant to capecitabine or allergic to any therapeutic drug, or who are participating in clinical studies of other new drugs; Diseases that may interfere with oral medication treatment, including but not limited to swallowing difficulties, chronic diarrhea, or intestinal obstruction; Previous or current history of other tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, and thyroid papillary carcinoma; Sever heart disease; Central nervous system metastasis with clinical symptoms; Serious infections ; Within 4 weeks of signing the informed consent form, receive systemic hormone or other immunosuppressive therapy with an equivalent dose greater than 10mg prednisone per day. Subjects with a systemic hormone dose ≤ 10mg prednisone per day or inhaled/topical corticosteroids can be enrolled in the study; Patients with active chronic hepatitis B or active hepatitis C. A history of interstitial pneumonia or other autoimmune diseases. HIV infection; Individuals with significant organ dysfunction or uncontrollable comorbidities, including but not limited to uncontrollable hypertension, decompensated liver cirrhosis, active peptic ulcer, or hemorrhagic disease; Less than 6 weeks after major organ surgery; Pregnant or breast feeding; Patients with mental illness, those with a history of alcohol or drug abuse, or those who are unable to obtain informed consent; Other researchers have determined that it is not suitable to participate in this trial. Those who refuse or are unable to sign the informed consent form.
Sites / Locations
- SunYat-senURecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Capecitabine combined with treprizumab maintenance group
Placebo combined with teriprizumab maintenance group
Capecitabine, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle Treprizumab, 240mg, intravenously, day 1 and 21 days/cycle
Placebo, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle Treprizumab, 240mg, intravenously, day 1 and 21 days/cycle