drugset / Trial / NCT04503967

Efficacy and Safety of Anlotinib Hydrochloride Combined With Nivolumab in the Treatment of Gastric and Esophageal Cancer

NCT04503967 ↗

Phase 2 Unknown 48 enrolled Shanghai Zhongshan Hospital
NaSingle-groupOpen-labelTreatment

Summary

Patients with unresectable or metastatic gastric or esophageal cancer, with first-line treatment applied are to be recruited in the study. In the current study, the efficacy and safety of anlotinib hydrochloride combined with nivolumab as second-line or salvage chemotherapy will be evaluated in Chinese patients with advanced gastric adenocarcinoma and esophageal squamous cell carcinoma. 48 patients could provide adequate precision rather than controlling type I\&II error.

Timeline

Start
2020-08-01
Primary completion
2021-02-01
Completion
2021-08-01

Outcome

Met primary endpoint

paper The pre-specified endpoints were reached, with the primary endpoint of overall response rate achieving 29.2%. PMID 39406730 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Catequentinib Small molecule — —
Subject Nivolumab Monoclonal antibody — —