NCT04385550

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

A Randomized, Open-label, Controlled, Multicenter Phase III Study of Hydrochloride Capsule Combined With AK105 Injection Versus Standard Second-line Chemotherapy for Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 528 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Anlotinib hydrochloride capsule	Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
DRUG	AK105 injection	AK105 200mg intravenously (IV) on Day 1 of each 21-day cycle.
DRUG	Paclitaxel injection	Paclitaxel injection 80mg / m² IV on Days 1, 8 and 15 of each 28-day cycle.
DRUG	Docetaxel injection	Docetaxel injection 75mg / m² IV every 3 weeks of each 21-day cycle.

Timeline

• Start date: 2020-05-20
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2020-05-13
• Last updated: 2020-05-13

Locations

45 sites across 1 country: China