To hear about similar clinical trials, please enter your email below
Trial Title:
TPC VS. GP Induced Chemotherapy Combined With Nimotuzumab and Toripalimab in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
NCT ID:
NCT06561763
Condition:
High Risk Locally Advanced Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Paclitaxel
Cisplatin
Gemcitabine
Capecitabine
Nimotuzumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabine
Description:
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
Arm group label:
TPC+Triprolizumab+Nimotuzumab
Intervention type:
Drug
Intervention name:
Nimotuzumab,Toripalimab，Cisplatin, Gemcitabine
Description:
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
Arm group label:
GP+Triprolizumab+Nimotuzumab
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
August 20, 2024
Completion date:
August 20, 2031
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06561763
