NCT06666166

SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer

Exploratory Clinical Study of SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Yunpeng Liu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effectiveness and safety of SHR-A1811 combined with apatinib in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.

Detailed description

This is a prospective, dual arm, exploratory clinical research. To evaluate the effectiveness and safety of SHR-A1811 combined with apatinib in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer. Cohort A will enroll subjects with advanced gastric or gastroesophageal junction adenocarcinoma, while Cohort B will enroll subjects with advanced colorectal cancer. The primary endpoint is objective remission rate (ORR). Secondary endpoints include disease control rate (DCR), duration of remission (DoR), progression-free survival (PFS), overall survival (OS) and safety.

Conditions

• Advanced Gastric Carcinoma
• Advanced Gastroesophageal Junction Adenocarcinoma
• Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	SHR-A1811 & Apartinib	SHR-A1811 injection will be administered by intravenous infusion. And apatinib will be administered orally.

Timeline

• Start date: 2024-12-01
• Primary completion: 2028-07-01
• Completion: 2028-12-01
• First posted: 2024-10-30
• Last updated: 2024-10-30

Locations

1 site across 1 country: China