NCT05111444

Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety of Camrelizumab plus pyrotinib in combination with chemotherapy in patients with HER2-positive gastric cancer.

Conditions

• Gastric Neoplasms
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	200 mg on Day 1 of each 3-week cycle as an IV infusion
DRUG	Pyrotinib	320mg as continuous oral once daily on every 21 days
DRUG	Capecitabine	1000 mg/m\^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of XELOX chemotherapy regimen
DRUG	Oxaliplatin	130 mg/m\^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of XELOX chemotherapy regimen and as part of SOX chemotherapy regimen
DRUG	Paclitaxel	80 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen
DRUG	S-1	Combination product of tegafur, CDHP, and Oxo. Oral capsules BID on Days 1-14 of each 3-week cycle based on body surface area (BSA): \<1.25 m\^2 BSA =40 mg, 1.25 to \<1.5 m\^2 BSA=50 mg, ≥1.5 m\^2 BSA=60 mg. Administered as part of SOX and TS chemotherapy regimen

Timeline

• Start date: 2021-12-31
• Primary completion: 2023-12-31
• Completion: 2024-06-30
• First posted: 2021-11-08
• Last updated: 2021-11-08

Locations

1 site across 1 country: China