NCT06202014

Phase II Study of Concurrent Radiotherapy With Envafolimab and Capecitabine in LAPC

Phase II Study of Concurrent Radiotherapy With Envafolimab and Capecitabine in Locally Advanced Pancreatic Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of concurrent radiotherapy with envafolimab and capecitabine in locally advanced pancreatic cancer.Eligibility patients will receive intensity-modulated radiotherapy(IMRT)or volumetric modulated arc therapy(VMAT) to pancreatic lesions,metastatic lymph nodes and high-risk lymphatic drainage areas,concurrent with and followed by envafolimab and capecitabine.

Detailed description

This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of concurrent radiotherapy with envafolimab and capecitabine in locally advanced pancreatic cancer.Primary enrollment criteria is locally advanced non-resectable pancreatic cancer without systemic metastases other than retroperitoneal lymph nodes.Eligibility patients will receive intensity-modulated radiotherapy(IMRT)or volumetric modulated arc therapy(VMAT) to pancreatic lesions,metastatic lymph nodes and high-risk lymphatic drainage areas,concurrent with and followed by envafolimab and capecitabine.Concurrent and sequential dose of envafolimab is 200mg subcutaneous injection weekly.Capecitabine is with a concurrent and sequential dose of 500-800 mg/m2 bid po , taken orally for 2 weeks and stopped for 1 week (standard concurrent dose is 800 mg/m2 bid po , but for patients ≥70 years of age, 500 mg/m2 bid po depending on physical status ) until progression or intolerance.

Conditions

• Pancreatic Cancer
• Radiotherapy
• Envafolimab
• Capecitabine

Interventions

Type	Name	Description
RADIATION	concurrent radiotherapy with envafolimab and capecitabine	Eligibility patients will receive intensity-modulated radiotherapy(IMRT)or volumetric modulated arc therapy(VMAT) to pancreatic lesions,metastatic lymph nodes and high-risk lymphatic drainage areas,concurrent with and followed by envafolimab and capecitabine.Concurrent and sequential dose of envafolimab is 200mg subcutaneous injection weekly.Capecitabine is with a concurrent and sequential dose of 500-800 mg/m2 bid po , taken orally for 2 weeks and stopped for 1 week (standard concurrent dose is 800 mg/m2 bid po , but for patients ≥70 years of age, 500 mg/m2 bid po depending on physical status ) until progression or intolerance.

Timeline

• Start date: 2024-01-31
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-01-11
• Last updated: 2024-01-19

Locations

1 site across 1 country: China