NCT06070740

First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma

First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Patients With Advanced Gastrointestinal Neuroendocrine Carcinoma: A Prospective Single-arm Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

First-Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma - a prospective Single-arm Phase II Study \[NCT ID not yet assigned\]

Detailed description

A prospective Single-arm Phase II Study to evaluate the effectiveness and safety of the combination treatment of durvalumab with XELOX chemotherapy as the first-line in advanced gastrointestinal neuroendocrine carcinoma

Conditions

• Gastrointestinal Neuroendocrine Carcinoma

Interventions

Type	Name	Description
DRUG	Durvalumab and Chemotherapy(oxaliplatin and capecitabine)	Combination therapy includes: Durvalumab: intravenous infusion with a fixed dose of 1500 mg on day 1, repeated every 3 weeks ± 3 days; Chemotherapy: Oxaliplatin 130mg/m2 intravenous infusion on day 1, capecitabine 1000mg/m2, orally, twice a day, from day 1 to day 14; repeated every 3 weeks ± 3 days; After 6 cycles of combination therapy, maintain with durvalumab 1500 mg every 4 weeks ± 3 days for 2 years. Terminate the trial if confirmed disease progression, initiation of other anti-tumor therapy, unacceptable toxicity, withdrawal of informed consent or other reasons considered by the investigators.

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2023-10-06
• Last updated: 2023-10-06

Locations

1 site across 1 country: China