NCT04891900

TQB2450 Plus Anlotinib Combined With Chemotherapy in the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma

A Single Arm, Multicenter Phase II Clinical Study of TQB2450 (PD-L1 Inhibitor) Plus Anlotinib Combined With Oxaliplatin, Capecitabine in the First-line Treatment of Advanced Gastric Cancer (GC) or Adenocarcinoma of Esophagogastric Junction (AEG)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective one arm phase II clinical study to evaluate the efficacy and safety of TQB2450 (PD-L1 inhibitor), anlotinib combined with oxaliplatin and capecitabine in patients with unresectable locally advanced, recurrent or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction.

Conditions

• Gastric Cancer
• Adenocarcinoma of Esophagogastric Junction

Interventions

Type	Name	Description
DRUG	TQB2450/Anlotinib hydrochloride/Oxaliplatin/Capecitabine	Initial treatment (6 cycles)： 1. TQB2450：1200 mg , Day 1 ivgtt ,once every 3 weeks 2. Anlotinib: 10 mg/day orally ，from days 1 to 14 in a 21-day cycle 3. Oxaliplatin: 130 mg / m2, Day 1 ivgtt ,once every 3 weeks 4. Capecitabine: 1000 mg / m2, orally, twice a day (once in the morning and once in the evening), from days 1 to 14 in a 21-day cycle Maintenance treatment： 1）TQB2450: 1200 mg , Day 1 ivgtt , once every 3 weeks 2）Anlotinib: 10 mg/day orally , from days 1 to 14 in a 21-day cycle

Timeline

• Start date: 2021-05-10
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2021-05-19
• Last updated: 2024-07-08

Locations

1 site across 1 country: China