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

Last updated: February 26, 2025
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Nasopharyngeal Cancer

Treatment

radiation

Toripalimab

Gemcitabine

Clinical Study ID

NCT06851247
2024-FXY-171-NPC
  • Ages 18-65
  • All Genders

Study Summary

In order to explore the efficacy and safety of targeted therapy and immunotherapy combined with GP chemotherapy in the treatment of high risk advanced nasopharyngeal carcinoma, the investigators design a single-arm, Phase II clinical trial targeted high-risk patients with local stage nasopharyngeal carcinoma (stage IVa: TanyN3M0/T4N0-2M0,8th AJCC/UICC staging) for Toripalimab Plus Anlotinib Combined With GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy.

Eligibility Criteria

Inclusion

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 orundifferentiated, i.e., WHO type II or III).

  • First treatment patients who did not receive antitumor therapy had no history ofother 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 vitalorgans.

  • 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), totalbilirubin <2.0×ULN.

  • Renal function: serum creatinine <1.5×ULN.

Exclusion

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 toenrollment.

  • Participants who had participated in other drug clinical trials within 3 monthsbefore treatment.

  • Patients with a known history of allogeneic organ transplantation or allogeneichematopoietic stem cell transplantation;

  • Patients with idiopathic pulmonary fibrosis, drug-induced pneumonia, institutionalpneumonia (i.e., bronchiolitis obliterans), radiation pneumonia with clinicalsymptoms or requiring steroid treatment, active pneumonia, or other moderate tosevere lung diseases that seriously affect lung function

  • Have a comorbiditis that requires long-term treatment with immunosuppressive drugsor systemic or local use of immunosuppressive doses of corticosteroids.

  • Prior use of anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, oranti-CTLA-4 antibodies (or any other antibody that acts on the T-cell co-stimulationor 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 withvitiligo or who had complete remission of asthma in childhood and did not requireany intervention as adults were included; Patients with asthma requiring medicalintervention with bronchodilators were not included).

  • Positive HBV DNA copy number was detected in HIV-positive patients and HBsAgpositive patients (quantitative detection ≥ 1000cps/ml); Chronic hepatitis C bloodscreening 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.

Study Design

Total Participants: 47
Treatment Group(s): 5
Primary Treatment: radiation
Phase: 2
Study Start date:
January 03, 2025
Estimated Completion Date:
June 30, 2027

Study Description

In order to explore the efficacy and safety of targeted therapy and immunotherapy combined with GP chemotherapy in the treatment of high risk advanced nasopharyngeal carcinoma, the investigators design a single-arm, Phase II clinical trial targeted high-risk patients with local stage nasopharyngeal carcinoma (stage IVa: TanyN3M0/T4N0-2M0,8th AJCC/UICC staging) for Toripalimab Plus Anlotinib Combined With GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy. The investigators focus on the 2-year PFS as the primary outcome.

Connect with a study center

  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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