nasopharyngeal carcinoma
Conditions
Interventions
Test group:PD-1 inhibitor plus chemoradiotherapy
Sponsors
Jiangxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathological histology confirmed it as non-keratinizing carcinoma of the nasopharynx; 2. Multiple metastatic nasopharyngeal carcinomas, that is, more than 5 metastatic lesions, but less than 16 metastatic lesions; 3. Has not received any anti-tumor treatment for recurrent or metastatic nasopharyngeal cancer in the past; 4. Patients aged 18 to 70; 5. ECOG performance status score (PS score) of 0 or 1; 6. The functions of major organs meet the following criteria: a. Neutrophil count >= 1.5 × 10^9/L, hemoglobin >= 90 g/L, and platelet count >= 90 × 10^9/L; b. Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) = 60 ml/min (calculated using the Cockcroft-Gault formula); 7. According to the RECIST 1.1 standard, there must be at least one measurable lesion; 8. Expected survival period >= 6 months; 9. Women with reproductive capacity and men with fertility should take medically recognized contraceptive measures during the study treatment period (at least 6 months after the last administration); 10. The subjects voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Has a history of allergy to any of the drugs such as PD-1 monoclonal antibody, gemcitabine and cisplatin, or their components; 2. History of other malignant tumors within the past 5 years or concurrently, except for cured cases such as skin basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid carcinoma; 3. Known active infections, or when the investigator determines that there are significant disorders in blood, kidneys, metabolism, gastrointestinal function, endocrine function or metabolic balance, or other severe uncontrolled concomitant diseases. 4. Those with a history of immune deficiency, including those with positive HIV test results or suffering from other acquired or congenital immune disorders, or those with a history of organ transplantation, or those with other immune-related diseases requiring long-term oral hormone therapy. 5. Those who are currently experiencing acute or chronic tuberculosis infections (patients with positive T-spot test results and suspicious tuberculosis lesions on chest X-rays). 6. It is known that there is a history of abuse of psychotropic drugs, alcoholism and drug use; 7. Pregnant or lactating women; 8. Other circumstances that, in the judgment of the researchers, may affect the safety of the subjects or the compliance of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the 1-year progression-free survival (PFS) rate of patients.;Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| To observe the 3-year overall survival (OS) rate of patients.; Disease control rate (DCR);Safety and efficacy; | — |
Countries
China
Contacts
Public ContactGong Xiaochang
Jiangxi Cancer Hospital
Outcome results
None listed