Actively Recruiting
De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2024-03-19
112
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In the IMRT era, patients with stage II-III (AJCC8th) nasopharyngeal carcinoma achieve high local control. However, survivors are increasingly experiencing late radiation-induced toxicities. A previous study found that reducing the radiation dose to the primary site to 60Gy for patients who achieved partial or complete response to induction chemotherapy resulted in a lower rate of late toxicities and an inferior local control rate. The investigators aim to reduce the radiation dose to the primary site for patients after immunochemotherapy, given the potential of neoadjuvant chemotherapy and immunotherapy to increase response rates and long-term survival. The protocol includes participants with stage II-III (AJCC8th), except T2N0M0, to receive three courses of neoadjuvant gemcitabine plus cisplatin and Toripalimab. If the primary tumour regresses by over 75%, de-escalated radiotherapy with 60Gy will be administered, and participants will receive two cycles of cisplatin and three cycles of Toripalimab during the radiotherapy course. Otherwise, participants will receive conventional radiotherapy and concurrent chemotherapy with cisplatin for two cycles as usual. The aim of this study is to investigate the 3-year local control rate and toxicities of de-escalated radiotherapy.
CONDITIONS
Official Title
De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed nasopharyngeal carcinoma with no prior anti-cancer therapy
- ECOG performance status score 0 or 1
- Age between 18 and 70 years
- Stage II-III disease except T2N0M0 (AJCC 8th edition)
- Neutrophil count at least 1.5 x 10^9/L, hemoglobin at least 90 g/L, and platelet count at least 100 x 10^9/L
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels no more than 2.5 times the upper limit of normal, bilirubin no more than 1.5 times upper limit, and creatinine clearance at least 60 ml/min
- Willing and able to sign informed consent and comply with study visits, treatment, and tests
You will not qualify if you...
- Age under 18 or over 70 years
- Hepatitis B surface antigen positive with HBV DNA 1 x 10^3 copies/ml or higher
- Hepatitis C virus antibody positive
- Active, known, or suspected autoimmune diseases except type 1 diabetes mellitus, hypothyroidism on hormone replacement, or certain skin conditions
- History of interstitial lung disease
- Use of systemic sex hormones or immunosuppressive therapy equivalent to at least 10 mg prednisone daily within 28 days before consent; low-dose or topical corticosteroids allowed
- Received or planned to receive live vaccines within 30 days before consent
- Pregnant or breastfeeding women
- Other cancers within 5 years except certain skin and thyroid cancers
- Known allergy to macromolecular proteins or Toripalimab components
- Human immunodeficiency virus (HIV) infection
- Other conditions affecting safety or compliance as judged by the investigator, including symptomatic heart failure, unstable angina, recent heart attack, active infection requiring systemic treatment, mental illness, or social factors
AI-Screening
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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
P
Puyun Ouyang
CONTACT
F
Fangyun Xie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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