GAPP Induction and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance for Nasopharyngeal Carcinoma.

Launched by SUN YAT-SEN UNIVERSITY · Feb 26, 2025

Keywords

ClinConnect Summary

This clinical trial, called GAPP, is studying a new treatment approach for patients with advanced nasopharyngeal carcinoma, a type of cancer that affects the area behind the nose. Researchers want to see if combining targeted therapy (using specific medications to attack cancer cells) and immunotherapy (helping the body’s immune system fight cancer) with standard chemotherapy and radiation can be effective and safe for patients with high-risk cancer. Participants will receive a combination of treatments, including Toripalimab and Anlotinib, followed by maintenance therapy with Toripalimab.

To be eligible for this trial, participants must be between 18 and 65 years old, diagnosed with a specific type of nasopharyngeal carcinoma (not the keratinized type), and have not received any previous cancer treatments. They should also have good overall health and function well without serious issues with vital organs. If you or a loved one is interested in this study, please keep in mind that there are specific health criteria to meet, and participation will involve regular follow-up appointments to monitor health and treatment effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Voluntarily participate in and sign informed consent in person.
• • Age 18-65, male or non-pregnant female.
• • Pathological diagnosis of nasopharyngeal non-keratonic carcinoma (differentiated or undifferentiated, i.e., WHO type II or III).
• • First treatment patients who did not receive antitumor therapy had no history of other malignant tumors;
• • Stage IVa: TanyN3M0/T4N0-2M0 (8th AJCC/UICC stage)
• • ECOG score 0-1, no serious dysfunction of heart, lung, liver, kidney and other vital organs.
• • Hemoglobin (HGB) ≥90 g/L, white blood cells (WBC) ≥4.0×109 /L, platelets (PLT) ≥100×109 /L.
• • Liver function: ALT and AST\< 2.5 times the upper limit of normal (ULN), total bilirubin \<2.0×ULN.
• • Renal function: serum creatinine \<1.5×ULN.
• Exclusion Criteria:
• • Patients with recurrent and distant metastasis of nasopharyngeal carcinoma.
• • The pathology was keratinized squamous cell carcinoma (WHO type I).
• • Received systemic or local glucocorticoid therapy within 4 weeks prior to enrollment.
• • Participants who had participated in other drug clinical trials within 3 months before treatment.
• • Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• • Patients with idiopathic pulmonary fibrosis, drug-induced pneumonia, institutional pneumonia (i.e., bronchiolitis obliterans), radiation pneumonia with clinical symptoms or requiring steroid treatment, active pneumonia, or other moderate to severe lung diseases that seriously affect lung function
• • Have a comorbiditis that requires long-term treatment with immunosuppressive drugs or systemic or local use of immunosuppressive doses of corticosteroids.
• • Prior use of anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibody that acts on the T-cell co-stimulation or checkpoint pathway), and efficacy was assessed as progressive at enrollment.
• • The subject has any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; Patients with vitiligo or who had complete remission of asthma in childhood and did not require any intervention as adults were included; Patients with asthma requiring medical intervention with bronchodilators were not included).
• • Positive HBV DNA copy number was detected in HIV-positive patients and HBsAg positive patients (quantitative detection ≥ 1000cps/ml); Chronic hepatitis C blood screening positive (HCV antibody positive) with HCV RNA positive detection.
• • Received any anti-infection vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment.
• • Pregnancy test positive women of childbearing age and breastfeeding women.
• • Patients who are unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.