The investigators have designed a multicenter, open-label, randomized controlled phase III clinical study of GAPP induction therapy followed by concurrent chemoradiotherapy and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition). The aim is to obtain high-level, high-quality evidence-based data to clarify the efficacy and safety of combining chemoradiotherapy with PD-1 antibody and anlotinib, thereby providing a new treatment strategy to improve the prognosis of patients with high-risk locoregionally advanced nasopharyngeal carcinoma. In this study, GPP induction chemotherapy followed by concurrent chemoradiotherapy and toripalimab maintenance therapy is selected as the control group. This regimen is currently the standard treatment recommended by guidelines for high-risk locoregionally advanced nasopharyngeal carcinoma, with well-established efficacy and broad clinical application. It provides a reliable benchmark for comparing the efficacy and safety of the experimental group, meets ethical requirements, and has mature clinical operational procedures.
The investigators have designed a multicenter, open-label, randomized controlled phase III clinical study of GAPP (gemcitabine + anlotinib + cisplatin + toripalimab) induction therapy followed by concurrent chemoradiotherapy (cisplatin) and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition). The aim is to obtain high-level, high-quality evidence-based data to clarify the efficacy and safety of combining chemoradiotherapy with PD-1 antibody and anlotinib, thereby providing a new treatment strategy to improve the prognosis of patients with high-risk locoregionally advanced nasopharyngeal carcinoma. In this study, GPP (gemcitabine + cisplatin + toripalimab) induction chemotherapy followed by concurrent chemoradiotherapy (cisplatin) and toripalimab maintenance therapy is selected as the control group. This regimen is currently the standard treatment recommended by guidelines for high-risk locoregionally advanced nasopharyngeal carcinoma, with well-established efficacy and broad clinical application. It provides a reliable benchmark for comparing the efficacy and safety of the experimental group, meets ethical requirements, and has mature clinical operational procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
442
Toripalimab, 240 mg per administration, on Day 1, diluted in 100 mL of normal saline, administered as an intravenous infusion over 30 minutes (no less than 20 minutes and no more than 60 minutes). After the toripalimab infusion, there should be an interval of 30-60 minutes before administering gemcitabine and cisplatin. Each treatment cycle is 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 9 cycles will be administered.
Anlotinib, 8 mg per dose per day, once daily on Days 1-14, taken orally before breakfast. Each treatment cycle is 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 3 cycles will be administered.
Cisplatin, with a treatment cycle of 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 5 cycles will be administered.
Gemcitabine, 1000 mg/m², on Days 1 and 8, diluted in 500 mL of 0.9% normal saline, administered as an intravenous infusion. Each treatment cycle is 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 3 cycles will be administered.
IMRT
Sun yat-sen university cancer center
Guangzhou, Guangdong, China
3-year progression-free survival
3-year progression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.