TPC VS. GP Induced Chemotherapy Combined With Nimotuzumab and Toripalimab in the Treatment of Locally Advanced Nasopharyngeal Carcinoma

Phase 3

Not yet recruiting

• Conditions: High Risk Locally Advanced Nasopharyngeal Carcinoma
• Interventions: Drug: Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabine; Drug: Nimotuzumab,Toripalimab，Cisplatin, Gemcitabine

• Registration Number: NCT06561763
• Lead Sponsor: Sun Yat-sen University

Brief Summary

We expect to conduct a clinical trial in high-risk locally advanced nasopharyngeal carcinoma patients to explore the efficacy and safety of sequential radical radiotherapy treatment after induction chemotherapy (TPC vs. GP) with combination therapy of nivolumab and triprolizumab.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-16
• Last Update Submitted: 2024-08-16
• Study Start: 2024-08-20
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20
• Primary Completion: 2028-08-20
• Study Completion: 2031-08-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

1. Age range: 18-65 years old;
2. Diagnosed with nasopharyngeal carcinoma through histopathology or cytology;
3. Advanced nasopharyngeal carcinoma, AJCC 8th standard stage III-IVA, excluding T3-4N0/T3N1;
4. ECOG score is 0-1;
5. Sufficient organ or bone marrow function:
6. Sign a written informed consent form

Exclusion Criteria

1. Diagnosed with other malignant tumors within 5 years prior to the first administration, excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ.
2. Symptomatic congestive heart failure, with echocardiogram indicating a left ventricular ejection fraction (LVEF)<50%.
3. Individuals infected with acute or chronic active hepatitis B or C, with hepatitis B virus (HBV) DNA>2000IU/ml or 10^4 copies/ml; Hepatitis C virus (HCV) RNA>10^3 copies/ml; Hepatitis B surface antigen (HbsAg) and anti HCV antibody were positive at the same time. After nucleotide antiviral treatment, if the score is lower than the above standard, it can be included in the group.
4. Past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function, and other lung diseases.
5. Individuals with active pulmonary tuberculosis (TB) who are currently receiving anti tuberculosis treatment or have received anti tuberculosis treatment within one year prior to their first dose.
6. Human immunodeficiency virus (HIV) infected individuals (HIV 1/2 antibody positive), known syphilis infections requiring treatment.
7. Severe infections that are active or poorly controlled clinically. Within 4 weeks prior to the first administration, there was a severe infection, including but not limited to hospitalization due to infection, bacteremia, or complications of severe pneumonia.
8. An active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants) has occurred within 2 years prior to the first administration. Allow the use of alternative therapies such as thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency. Known history of primary immunodeficiency. Only patients with positive autoimmune antibodies need to confirm the presence of autoimmune diseases based on the researcher's judgment.
9. Pregnant or lactating female patients.
10. Has received radiotherapy, chemotherapy, or surgical treatment for nasopharyngeal and neck lesions (excluding biopsy).
11. History of allergies to the drugs and their components used in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPC+Triprolizumab+Nimotuzumab	Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabine	-
GP+Triprolizumab+Nimotuzumab	Nimotuzumab,Toripalimab，Cisplatin, Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
3-year event free survival	3 years

Secondary Outcome Measures

Name	Time	Method
3-year local recurrence free survival rate	3 years
3-year overall survival	3 years
3-year distant disease free survival	3 years
adverse effects	3 years	chemotherapy side effectst