Actively Recruiting
Toripalimab vs. Placebo Wtih GP Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2025-03-18
466
Participants Needed
1
Research Sites
358 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
F
First Affiliated Hospital of Guangxi Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main questions it aims to answer are: 1. Does the combination of GP induction chemotherapy and toripalimab improve the 3-year progression-free survival (PFS) compared to GP induction chemotherapy with placebo? 2. What are the differences in CR after induction therapy, 3-year overall survival (OS), locoregional progression, and distant progression between the two groups? 3. What are the differences in safety between the two groups? 4. Are there predictive biomarkers of therapeutic efficacy, such as changes in EBV DNA or immune parameters, that correlate with treatment outcomes? Researchers will compare the GP + toripalimab group with the GP + placebo group to see if the toripalimab combination shows superior efficacy. Participants will: Receive either GP chemotherapy with toripalimab or GP chemotherapy with placebo as induction therapy. Undergo concurrent chemoradiotherapy ± adjuvant metronomic capecitabine following induction therapy. Be monitored closely for safety and efficacy outcomes.
CONDITIONS
Official Title
Toripalimab vs. Placebo Wtih GP Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate and signs informed consent.
- Age between 18 and 70 years, male or non-pregnant female.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (WHO Type II or III).
- Cancer staging of any T with N2-3 or T4N1, without distant metastasis.
- ECOG performance status of 0 or 1.
- Hemoglobin level at least 90 g/L, neutrophil count at least 1.5 x 10^9/L, and platelet count at least 100 x 10^9/L.
- Liver function with ALT and AST not exceeding 2.5 times upper limit of normal, and bilirubin at or below 1.5 times upper limit of normal.
- Adequate kidney function with creatinine clearance rate at least 60 ml/min.
- Women of childbearing potential and sexually active men must use effective contraception during treatment and for 1 year after last dose.
You will not qualify if you...
- Age under 18 years or over 70 years.
- Patients with recurrence or distant metastases.
- Pathologically confirmed nasopharyngeal keratinizing squamous cell carcinoma (WHO Type I).
- Previous radiotherapy or systemic chemotherapy.
- Positive hepatitis B surface antigen with HBV DNA over 1000 copies/ml or 200 IU/ml.
- Positive hepatitis C virus antibody.
- Active autoimmune disease except type I diabetes, hypothyroidism on replacement therapy, or skin disease not requiring systemic treatment.
- Use of systemic corticosteroids above prednisone 10 mg/day or other immunosuppressive therapy within 28 days before consent.
- Active tuberculosis within 1 year (treated tuberculosis over 1 year ago allowed).
- History of interstitial lung disease.
- Receipt of live vaccine within 30 days before consent or planned live vaccination soon.
- Pregnancy or breastfeeding.
- Prior malignancy within 5 years except certain treated cancers.
- Allergy to large molecule protein products or toripalimab components.
- Known HIV infection.
- Other conditions that may interfere with consent, cooperation, participation, or result interpretation, including heart failure, unstable angina, recent heart attack, active infections needing systemic therapy, mental illness, or social factors.
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
Hai-Qiang Mai, Ph. D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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