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Esophageal squamous cell carcinoma is the main subtype of esophageal cancer, accounting for about 90% of all esophageal cancers
Currently, first-line therapy for patients with advanced or metastatic ESCC is limited to platinum-based chemotherapy
To evaluate the efficacy and safety of sintilimab vs placebo in combination with chemotherapy (cisplatin + paclitaxel or cisplatin + 5-fluorouracil) as first-line treatment for unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma
This is a multicenter, randomized, double-blind phase 3 trial conducted at 66 sites in China and 13 sites abroad, recruiting patients aged 18 years and older with advanced or metastatic esophageal squamous cell carcinoma who have not received systemic therapy
Between December 14, 2018, and April 9, 2021, a total of 659 patients were recruited and randomized into two groups: 327 in the sintilimab group and 332 in the placebo group
Both in the overall population and in patients with a PD-L1 expression combined positive score of ≥10, patients in the sintilimab group had longer overall survival compared with placebo in both the overall population and PD- In patients with L1 expression combined with a positive score of ≥10, the overall survival of patients in the sintilimab group was significantly longer compared with the placebo group.
In conclusion, compared with placebo combined with chemotherapy, sintilimab combined with chemotherapy as first-line treatment for patients with advanced or metastatic esophageal squamous cell carcinoma can significantly prolong their overall survival and progression-free survival
Compared with placebo plus chemotherapy, sintilimab plus chemotherapy as first-line treatment for patients with advanced or metastatic esophageal squamous cell carcinoma significantly prolongs overall survival and progression-free survival
Original source:
Original source:Lu Zhihao, Wang Junye, Shu Yongqian et al.
Lu Zhihao, Wang Junye, Shu Yongqian et al.
Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial.
[J ] .
BMJ, 2022, 377: e068714.
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