The Efficacy and Safety of Maintenance Therapy With Toripalimab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma:Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study

SYSKY-2023-307-02

The aim of this study is to investigate the efficacy and safety of the "capecitabine combined with toripalimab maintenance regimen" in improving the first-line treatment of recurrent and metastatic nasopharyngeal carcinoma after receiving remission through chemotherapy combined with anti PD-1 monoclonal antibody standard regimen.

2023-04-28

2026-04-28

2029-04-28

Recruiting

Early phase I

166

Inclusion Criteria: 1. The age at the time of diagnosis is 18-75 years old, regardless of gender; 2. Histologically confirmed nasopharyngeal carcinoma; 3. Confirm the presence of distant metastasis in advanced nasopharyngeal carcinoma patients or recurrent nasopharyngeal carcinoma patients who cannot receive local treatment. ; 4. After receiving standard treatment for 4-6 cycles, the disease is control; 5. ECOG score 0-1; 6. Expected survival time of at least 12 weeks; 7. Patients who have not received systemic chemotherapy within 6 months prior to diagnosis ; 8. According to RECIST 1.1 standard, at least 1 measurable lesion; 9. Enough organ function; 10. Sign an informed consent form; 11. 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: 1. 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; 2. Diseases that may interfere with oral medication treatment, including but not limited to swallowing difficulties, chronic diarrhea, or intestinal obstruction; 3. Previous or current history of other tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, and thyroid papillary carcinoma; 4. Sever heart disease; 5. Central nervous system metastasis with clinical symptoms; 6. Serious infections ; 7. 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; 8. Patients with active chronic hepatitis B or active hepatitis C. 9. A history of interstitial pneumonia or other autoimmune diseases. 10. HIV infection; 11. Individuals with significant organ dysfunction or uncontrollable comorbidities, including but not limited to uncontrollable hypertension, decompensated liver cirrhosis, active peptic ulcer, or hemorrhagic disease; 12. Less than 6 weeks after major organ surgery; 13. Pregnant or breast feeding; 14. Patients with mental illness, those with a history of alcohol or drug abuse, or those who are unable to obtain informed consent; 15. Other researchers have determined that it is not suitable to participate in this trial. 16. Those who refuse or are unable to sign the informed consent form.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 166, 'type': 'ESTIMATED'}}

2024-06-03