NCT04510818

Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 2)

Phase 1 Trail to Observe Safety and Efficacy of Metronomic Capecitabine Plus Camrelizumab as Second-line Regimen to Treat Head and Neck Cancer or Esophageal Squamous Cancer Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single center phase 1 trail to observe safety and efficacy of metronomic Capecitabine plus Camrelizumab as second-line regimen to treat head and neck cancer or esophageal squamous cancer patients. This study is one of the cohorts of a multi-cohort trial called Combination of Metronomic Capecitabine with Camrelizumab for treatment of refractory solid tumor (McCrest) trial.

Detailed description

Head and neck cancer / Esophageal squamous cancer patients who have disease progression after first standard regimen will be treated by metronomic Capecitabine plus Camrelizumab. Metronomic Capecitabine will be given as fixed dose (500mg bid) orally. Camrelizumab will be given two-weekly (200mg once) intravenously. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.

Conditions

• Head and Neck Cancer
• Esophageal Squamous Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine, Camrelizumab	This is a single-arm study with all patients receiving these two drugs.

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-08-01
• Completion: 2024-08-01
• First posted: 2020-08-12
• Last updated: 2020-08-14

Locations

1 site across 1 country: China