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

Pancreatic Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06202014
Study type Interventional
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Bo Chen, MD
Phone 008613240000876
Email cbchinese@163.com
Status Recruiting
Phase Phase 2
Start date January 31, 2024
Completion date December 31, 2025
View Details
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