NCT06759090

Metronomic Capecitabine with Camrelizumab and Apatinib Mesylate for Treatment of Advanced Pancreatic Cancer

Metronomic Capecitabine with Camrelizumab and Apatinib Mesylate in Advanced Pancreatic Cancer：A Multi-center, Single-arm, Phase II Exploratory Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, single-arm, phase II exploratory study, aims to evaluate the efficacy and safety of metronomic capecitabine with camrelizumab and apatinib mesylate in advanced pancreatic cancer after the failure of first-line treatment.

Detailed description

This study used a Simon two-stage design, with at least 43 subjects enrolled, includs the patients with advanced pancreatic cancer whose second-line treatment has failed, or those with poor performance status (PS score \>1) who cannot tolerate the second-line regimen with two or more chemotherapeutic drugs. All subjects enrolled receive the treatment of metronomic capecitabine with camrelizumab and apatinib mesylate until disease progression or intolerable toxicity or the ended of study.

Conditions

• Metastatic Pancreatic Carcinoma

Interventions

Type	Name	Description
DRUG	Metronomic capecitabine	Metronomic capecitabine: 650 mg/m2, twice daily, to be swallowed with water within 30 minutes after a meal;
DRUG	Camrelizumab	Camrelizumab: a PD-1 inhibitor, 200 mg, intravenous injection once every 2 weeks;
DRUG	Apatinib Mesylate Tablets	Apatinib mesylate: a small molecule of tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR-2) , 250mg, once daily, to be swallowed with water within 30 minutes after a meal.

Timeline

• Start date: 2025-01-15
• Primary completion: 2027-01-15
• Completion: 2028-06-15
• First posted: 2025-01-06
• Last updated: 2025-01-06

Locations

1 site across 1 country: China