NCT05193292

Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer

Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer: A Prospective, Single-arm, Open-label Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to evaluate the efficacy and safety of camrelizumab combined with trastuzumab and chemotherapy in Patients with HER2-positive advanced colorectal cancer

Conditions

• Colorectal Neoplasms
• Intestinal Neoplasms

Interventions

Type	Name	Description
DRUG	Camrelizumab	200mg, iv, 21d for a treatment cycle
DRUG	Trastuzumab	8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle
DRUG	XELOX regimen	Oxaliplatin, 130 mg/m2, iv, d1; Capecitabine, 1000 mg/m2, po, bid, d1-d14; q3w
DRUG	mFOLFOX6 regimen	Oxaliplatin, 85 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)\*2d, civ, 46h; q2w
DRUG	FOLFIRI regimen	Irinotecan, 180 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)\*2d, civ, 46h; q2w
DRUG	mXELIRI regimen	Irinotecan, 200 mg/m2, iv, d1; capecitabine, 800 mg/m2, po, bid, d1-d14; q3w
DRUG	mIRIS regimen	Irinotecan, 180 mg/m2, iv, d1; Tiggio Capsules (S-1), 40-60 mg/m2, po, bid, d1-d9; q2w

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-01-01
• Completion: 2025-01-01
• First posted: 2022-01-14
• Last updated: 2022-01-14

Locations

1 site across 1 country: China