China News Service, Guangzhou, September 15 (Cai Minjie, Chen Yun) Sun Yat-sen University Cancer Center said on the 15th that the center has completed a large-scale prospective phase III clinical study in conjunction with multiple hospitals and innovated the domestic immunological drug Carriolizumab Monoclonal antibody combined with chemotherapy in the first-line treatment of advanced esophageal squamous cell carcinoma has improved the quality of life of patients with esophageal cancer.

　　On September 14, 2021 local time in the United States, the full text of the study was published in the top international medical journal "Journal of the American Medical Association".

Professor Xu Ruihua of Sun Yat-sen University Cancer Center is the corresponding author, and Deputy Chief Physician Luo Huiyan is the first author.

　　Esophageal cancer is a gastrointestinal tumor with a high incidence in China. It is different from the pathological characteristics of adenocarcinoma in European and American countries. More than 90% of esophageal cancer in China is pathologically characterized as squamous cell carcinoma.

For patients with advanced esophageal squamous cell carcinoma, the current first-line standard treatment is dual-agent chemotherapy, but chemotherapy alone is not effective, with an effective rate of about 30%, and a median survival time of less than one year. It is urgent to explore more effective methods for Chinese patients with esophageal cancer Treatment to prolong survival.

　　PD-1 (programmed cell death protein-1) and its ligand (PD-L1) inhibitor are a new type of immunotherapy.

PD-1 inhibitors can bind to human PD-1 receptors and block the PD-1/PD-L1 pathway, restore the body's anti-tumor immunity, and exert a powerful anti-tumor effect.

Studies in other cancers have shown that PD-1 inhibitors combined with chemotherapy may further improve the efficacy, but there is still a lack of corresponding evidence in esophageal squamous cell carcinoma.

　　To this end, Professor Xu Ruihua led a randomized, double-blind, placebo-controlled Phase III clinical study to evaluate PD-1 monoclonal antibody (carrelizumab) combined with paclitaxel and cisplatin compared with placebo combined The effectiveness and safety of paclitaxel and cisplatin in the first-line treatment of advanced esophageal squamous cell carcinoma.

　　From December 3, 2018 to May 12, 2020, a total of 596 subjects were enrolled in the study. They were randomly enrolled according to 1:1 and received PD-1 antibody combined with paclitaxel and cisplatin or placebo combined with paclitaxel and cisplatin. Platinum treatment, receiving PD-1 antibody or placebo maintenance treatment after 6 courses, the longest time is 2 years.

　　The results showed that compared with 12.0 months in the placebo + chemotherapy group, PD-1 antibody combined with chemotherapy can prolong the median survival of patients with advanced esophageal squamous cell carcinoma to 15.3 months, and the median progression-free survival from 5.6 months Extend to 6.9 months, and has good safety.

　　The results showed that the PD-1 antibody combined with paclitaxel and cisplatin in the first-line treatment of patients with advanced esophageal squamous cell carcinoma can significantly prolong the progression-free survival and overall survival of patients compared with standard first-line chemotherapy.

　　Xu Ruihua said that the above-mentioned study is the first clinical study on the first-line immunotherapy of esophageal squamous cell carcinoma.

This study not only confirmed the effectiveness of combined immunotherapy for patients with advanced esophageal squamous cell carcinoma, but also achieved the longest overall survival time (15.4 months) and the highest effective rate (72.1%) of the current first-line treatment. The study is for the esophagus The immune combination therapy of cancer adds a new program, and points out the direction for the exploration of neoadjuvant therapy for esophageal cancer.

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