Treatment for advanced nasopharyngeal carcinoma using targeted therapy and immunotherapy.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of combining targeted therapy and immunotherapy with GP chemotherapy for patients with high-risk advanced nasopharyngeal carcinoma. It is a single-arm, Phase II trial focusing on patients with local stage IVa nasopharyngeal carcinoma. Participants will receive Toripalimab and Anlotinib alongside Gemcitabine and Cisplatin, followed by maintenance therapy with Toripalimab. The primary outcome measure is the two-year progression-free survival (PFS).

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yi-Jun Hua, Phd.
• Email: huayj@sysucc.org.cn
• Phone: 18820019088

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.