Treatment for advanced nasopharyngeal carcinoma using targeted therapy and immunotherapy.

Toripalimab Plus Anlotinib Combined with GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for High-risk, Locally Advanced Nasopharyngeal Carcinoma：A Single-arm, Phase II Clinical Trial

This study is testing a new combination of targeted therapy and immunotherapy with chemotherapy to see if it helps people with advanced nasopharyngeal cancer live longer without their disease getting worse.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: radiation, Toripalimab, Anlotinib, chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06851247 on ClinicalTrials.gov

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).

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a pathological diagnosis of non-keratonic nasopharyngeal carcinoma at stage IVa.

Not a fit: Patients with recurrent or metastatic nasopharyngeal carcinoma or those with keratinized squamous cell carcinoma will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could significantly improve outcomes for patients with advanced nasopharyngeal carcinoma.

How similar studies have performed: While this approach combines established therapies, the specific combination of Toripalimab and Anlotinib with GP chemotherapy in this context is novel.

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.

Where this trial is running

Guangzhou, Guangdong

• Sun yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Yi-Jun Hua, Phd.

Conditions: Nasopharyngeal Carcinoma