Efficacy and Safety of GP Chemotherapy Regimen Plus Camrelizumab Combined with Apatinib as First-Line Treatment for Nasopharyngeal Carcinoma with Liver Metastasis: A Prospective, Single-Arm, Open-Label Phase II Clinical Study

Phase 2

Conditions: nasopharyngeal carcinoma

Registration Number: ChiCTR2400089020

Lead Sponsor: Sun Yat-sen University Cancer Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Voluntarily participate and provide written informed consent. 2. Aged 18-75 years, both males and females are eligible. 3. Pathologically confirmed WHO type II or III nasopharyngeal carcinoma. 4. Patients with newly diagnosed or post-treatment liver metastasis of nasopharyngeal carcinoma, regardless of whether other sites of metastasis are present. 5. At least one measurable liver metastatic lesion (according to RECIST 1.1 criteria). 6. Good general condition, ECOG performance status score of 0-1, with an expected survival of =3 months. 7. No history of other malignant tumors. 8. No severe dysfunction of vital organs (heart, lung, liver, kidney) or bone marrow: •Absolute neutrophil count (ANC) = 1.5 × 10^9/L (1,500/mm³); Platelet count = 100 × 10^9/L (100,000/mm³); Hemoglobin = 9.0 g/dL •Serum creatinine = 1.5 × ULN or calculated creatinine clearance (CrCl) = 50 mL/min (using Cockcroft-Gault formula) •Serum total bilirubin (TBil) = 3 × ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 5 × ULN •Serum albumin = 28 g/L •Thyroid-stimulating hormone (TSH) = 1 × ULN (If abnormal, FT3 and FT4 levels should also be assessed. If FT3 and FT4 levels are normal, the patient can be enrolled.) •International normalized ratio (INR) and activated partial thromboplastin time (APTT) = 1.5 × ULN 9. Women of childbearing potential must ensure the use of effective contraception during the study period.

Exclusion Criteria

Pathology confirmed keratinizing squamous cell carcinoma (WHO type I). 2. Patients with recurrent advanced nasopharyngeal carcinoma after prior radiotherapy. 3. Known or suspected allergy to any of the study drugs, or currently participating in another investigational drug study. 4. Previous treatment with VEGFR small molecule tyrosine kinase inhibitors such as Apatinib, Sorafenib, Sunitinib, or Pazopanib. 5. Patients who have experienced any CTCAE v5.0 grade 3 or higher bleeding events within 4 weeks prior to screening, or those deemed by the investigator to be at high risk of bleeding; imaging showing tumor invasion of major blood vessels or a high likelihood of fatal bleeding due to tumor invasion during treatment as judged by the investigator (e.g., retropharyngeal lymph nodes, cervical lymph nodes, hilar lymph nodes, mediastinal lymph nodes, or tumor lesions invading blood vessels). 6. Refusal to sign the informed consent form. 7. Inability to comply with regular follow-up due to psychological, social, familial, or geographical reasons. 8. HIV infection or known acquired immunodeficiency syndrome (AIDS). 9. Untreated active hepatitis (hepatitis B, defined as HBV-DNA = 500 IU/ml; hepatitis C, defined as HCV-RNA above the lower limit of detection by the analytical method) or co-infection with both hepatitis B and C. 10. Known history of active tuberculosis (TB). Subjects suspected of having active TB must be excluded by chest X-ray, sputum tests, and clinical symptoms and signs. 11. Major organ dysfunction, such as decompensated heart, lung, kidney, or liver failure, that would preclude tolerance to chemoradiotherapy. 12. Metastatic brain tumors or leptomeningeal disease with symptoms. 13. Long-term use of immunosuppressive drugs following organ transplantation, or patients with autoimmune diseases. 14. History of gastrointestinal perforation and/or fistula. 15. History of other malignant tumors prior to enrollment. 16. Conditions affecting oral medication intake (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.). 17. Hypertension that is not well controlled with antihypertensive therapy (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg; average of = 2 BP readings), previous hypertensive crisis, or hypertensive encephalopathy. 18. Renal insufficiency: urine protein = ++ on routine urinalysis and confirmed 24-hour urine protein > 1.0 g. 19. Uncontrolled cardiac clinical symptoms or diseases, such as NYHA class 2 or higher heart failure; unstable angina; myocardial infarction within the past year; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; QTc > 450 ms (male); QTc > 470 ms (female). 20. Pregnant or breastfeeding women. 21. Any condition that the investigator believes may pose a risk to the subject if they receive the study drug or that may interfere with the evaluation of the study drug, subject safety, or interpretation of study results.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
9.6 Months Progression-Free Survival (PFS) Rate;

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR);Disease Control Rate (DCR);Duration of Response (DoR);Progression-Free Survival (PFS);Overall Survival (OS);Acute and Chronic Toxicity;Quality of Life;Exploratory Prognostic Biomarkers;