The New England journal of medicine · 2026
Neoadjuvant GOLP in Resectable High-Risk Intrahepatic Cholangiocarcinoma.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Shi Guo-Ming, Huang Xiao-Yong, Liang Fei, Liang Xiao, Dong Rui, Ye Qing-Hai, Gao Qiang, Ji Yuan, Yu Zheng-Ping, Zhai Wen-Long, Lu Jia-Cheng, Li Xiao-Wu, Liu Fu-Bao, Wang Kui, Yang Wei, Zhang Jia-Lin, Hu Zhi-Qiang, Qiu Shuang-Jian, Wang Xiao-Ying, Yang Xin-Rong, Sun Hui-Chuan, Shi Ying-Hong, Ding Zhen-Bin, Liu Wei-Ren, Huang Xiao-Wu, Huang Cheng, Shen Ying-Hao, Sun Jian, He Yi-Feng, Peng Yuan-Fei, Xu Yang, Zou Jian-Jun, Zhou Jian, Fan Jia, ZSAB Study Group
Аннотация
BACKGROUND: No neoadjuvant treatment has been considered to be standard therapy for patients with resectable intrahepatic cholangiocarcinoma with high-risk factors for recurrence. The GOLP regimen (gemcitabine-oxaliplatin, lenvatinib, and an anti-programmed death 1 antibody) has shown promising efficacy with a manageable safety profile in advanced intrahepatic cholangiocarcinoma and biliary tract cancer.
METHODS: In a phase 2-3 trial, we randomly assigned, in a 1:1 ratio, patients with resectable high-risk intrahepatic cholangiocarcinoma to the neoadjuvant group (intravenous gemcitabine-oxaliplatin plus toripalimab every 3 weeks for three cycles and oral lenvatinib once daily for 9 weeks, followed by curative resection) or the control group (curative resection and no neoadjuvant treatment). All patients received adjuvant capecitabine for eight cycles after surgery. The primary end point was event-free survival. Secondary end points included overall survival and safety.
RESULTS: A total of 178 patients underwent randomization (88 patients to the neoadjuvant group and 90 to the control group). At the interim analysis at a median follow-up of 16.9 months, the median event-free survival was significantly longer in the neoadjuvant group (18.0 months; 95% confidence interval [CI], 13.8 to 27.6) than in the control group (8.7 months; 95% CI, 7.2 to 12.4) (P<0.001). Overall survival at 24 months was 79% (95% CI, 70 to 90) in the neoadjuvant group and 61% (95% CI, 50 to 75) in the control group (hazard ratio for death, 0.43; 95% CI, 0.23 to 0.79; P = 0.005, which did not meet the significance criterion [two-sided alpha, 0.0019]). Across all treatment phases, adverse events occurred in 97% of the patients in the neoadjuvant group and in 70% of those in the control group. During the neoadjuvant phase, adverse events of grade 3 or higher occurred in 28% of the patients, and treatment-related adverse events of grade 3 or higher in 26%. No treatment-related adverse event led to death.
CONCLUSIONS: Neoadjuvant GOLP led to significantly longer event-free survival than control therapy, with mainly low-grade adverse events, among patients with resectable high-risk intrahepatic cholangiocarcinoma. (Funded by the Clinical Research Plan of Shanghai Hospital Development Center and others; ZSAB-neoGOLP ClinicalTrials.gov number, NCT04669496.).
METHODS: In a phase 2-3 trial, we randomly assigned, in a 1:1 ratio, patients with resectable high-risk intrahepatic cholangiocarcinoma to the neoadjuvant group (intravenous gemcitabine-oxaliplatin plus toripalimab every 3 weeks for three cycles and oral lenvatinib once daily for 9 weeks, followed by curative resection) or the control group (curative resection and no neoadjuvant treatment). All patients received adjuvant capecitabine for eight cycles after surgery. The primary end point was event-free survival. Secondary end points included overall survival and safety.
RESULTS: A total of 178 patients underwent randomization (88 patients to the neoadjuvant group and 90 to the control group). At the interim analysis at a median follow-up of 16.9 months, the median event-free survival was significantly longer in the neoadjuvant group (18.0 months; 95% confidence interval [CI], 13.8 to 27.6) than in the control group (8.7 months; 95% CI, 7.2 to 12.4) (P<0.001). Overall survival at 24 months was 79% (95% CI, 70 to 90) in the neoadjuvant group and 61% (95% CI, 50 to 75) in the control group (hazard ratio for death, 0.43; 95% CI, 0.23 to 0.79; P = 0.005, which did not meet the significance criterion [two-sided alpha, 0.0019]). Across all treatment phases, adverse events occurred in 97% of the patients in the neoadjuvant group and in 70% of those in the control group. During the neoadjuvant phase, adverse events of grade 3 or higher occurred in 28% of the patients, and treatment-related adverse events of grade 3 or higher in 26%. No treatment-related adverse event led to death.
CONCLUSIONS: Neoadjuvant GOLP led to significantly longer event-free survival than control therapy, with mainly low-grade adverse events, among patients with resectable high-risk intrahepatic cholangiocarcinoma. (Funded by the Clinical Research Plan of Shanghai Hospital Development Center and others; ZSAB-neoGOLP ClinicalTrials.gov number, NCT04669496.).
Предметные рубрики MeSH
AgedFemaleHumansMaleMiddle AgedAntineoplastic Combined Chemotherapy ProtocolsBile Duct NeoplasmsChemotherapy, AdjuvantCholangiocarcinomaGemcitabineKaplan-Meier EstimateNeoadjuvant TherapyOxaliplatinBile Ducts, IntrahepaticAntibodies, Monoclonal, HumanizedPhenylurea CompoundsQuinolinesProgression-Free SurvivalChinaFollow-Up StudiesCapecitabineImmune Checkpoint InhibitorsProgrammed Cell Death 1 ReceptorTreatment Outcome