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

TPC Versus GP Induced Chemotherapy Combined With Nimotuzumab and Toripalimab in the Treatment of Localized Advanced Nasopharyngeal Carcinoma:Multi Center, Open Label, Randomized Controlled, Non Inferiority Design, Phase III Clinical Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: High Risk Locally Advanced Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabine; Drug: Nimotuzumab,Toripalimab，Cisplatin, Gemcitabine

• Study Type: Interventional
• Enrollment (Estimated): 416
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPC+Triprolizumab+Nimotuzumab	Drug: Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabine; Albumin paclitaxel 200g/m2, intravenous drip administration, d1; Cisplatin 60 mg/m2， Intravenous , d1; Capecitabine, 1000mg/m2, orally administered D1-14； Triprolizumab injection 240mg, intravenous D1; Nivolumab 400mg, intravenous D1; Q3W 1 cycle, 3 cycles Period, 3 weeks in total
Active Comparator: GP+Triprolizumab+Nimotuzumab	Drug: Nimotuzumab,Toripalimab，Cisplatin, Gemcitabine; Cisplatin 80 mg/m2， Intravenous drip administration, d1; Gemcitabine, 1000mg/m2,Intravenous ，D1,D8； Triprolizumab injection 240mg, intravenous ； Nivolumab 400mg, intravenous； Q3W 1 cycle, 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
3-year event free survival	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year overall survival		3 years
adverse effects	chemotherapy side effectst	3 years
3-year distant disease free survival		3 years
3-year local recurrence free survival rate		3 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2024
• Primary Completion (Estimated): August 20, 2028
• Study Completion (Estimated): August 20, 2031

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Paclitaxel; Cisplatin; Capecitabine; Nimotuzumab; Gemcitabine
• Other Study ID Numbers: SYSKY-2024-568-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No