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drugset / Trial / NCT04385550

A Study of Anlotinib Hydrochloride Capsule Combined With AK105 Injection in Subject With Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma

NCT04385550 ↗

Phase 3 Unknown 528 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus standard second-line chemotherapy. Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or standard second-line chemotherapy, with 1:1 random ratio.

Timeline

Start
2020-05-20
Primary completion
2023-10-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Catequentinib Small molecule 12 mg Oral
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Penpulimab Monoclonal antibody 200 mg Intravenous

Indications

gastroesophageal adenocarcinoma