Status:
NOT_YET_RECRUITING
GP Combined with Toripalimab Versus GP Induction Chemotherapy for Advanced Childhood Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Cancinoma (NPC)
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief Summary
Nasopharyngeal carcinoma (NPC) has a low incidence rate in children, accounting for only 1-2% of pediatric tumors. However, it is prone to metastasis, and most patients are already in advanced stages ...
Eligibility Criteria
Inclusion
- Patients must be informed of the investigational nature of this study and give written informed consent.
- Age between 6 and 18 years, regardless of gender.
- Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO Type II or III).
- Clinical stage II-III (according to AJCC 9th edition), excluding T3N0 and T3N1 (only with retropharyngeal lymph node metastasis); patients must be newly diagnosed with nasopharyngeal carcinoma.
- ECOG performance status of 0-1.
- Females of childbearing potential must agree to use contraception during the study period.
- Hemoglobin (HGB) ≥ 90 g/L, white blood cell count (WBC) ≥ 4×10\^9/L, platelet count (PLT) ≥ 100×10\^9/L.
- Normal liver function test: ALT and AST \< 2.5 x upper limit of normal (ULN), total bilirubin \< 2.0×ULN.
- Adequate renal function: Serum creatinine \< 1.5×ULN.
Exclusion
- Older than 18 years.
- Presence of recurrence or distant metastasis.
- Pathologically diagnosed as keratinizing squamous cell carcinoma (WHO Type I).
- History of previous anti-tumor treatment.
- Pregnant or lactating women, and women of childbearing potential not using effective contraception.
- HIV positive.
- History of malignancy within the past 5 years, except for patients with carcinoma in situ, adequately treated non-melanoma skin cancer, or papillary thyroid carcinoma.
- Patients with other immunodeficiency diseases or a history of organ transplantation.
- Patients with active autoimmune diseases, except for type I diabetes, hypothyroidism under replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
- Conditions requiring systemic corticosteroids (equivalent to prednisone greater than 10mg/d) or other immunosuppressive therapy within 28 days prior to signing informed consent. Patients on systemic corticosteroids equivalent to prednisone ≤10 mg/day or using inhaled or topical corticosteroids are permitted.
- Received a live vaccine within 30 days before signing informed consent or planning to receive a live vaccine in the near future.
- Patients with significant impairment in heart, liver, lung, kidney, or bone marrow function.
- Severe, uncontrolled medical diseases or infections.
- Concurrent use of other investigational drugs or participation in other clinical trials.
- Refusal or inability to sign the informed consent form to participate in the trial.
- Known allergies to large molecule protein products or any PD-1 antibody compounds, or those with other contraindications to the treatment.
- Individuals with personality or mental disorders, those without legal capacity or with limited legal capacity.
Key Trial Info
Start Date :
April 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 25 2029
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06605131
Start Date
April 17 2025
End Date
February 25 2029
Last Update
March 20 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060