Sequence and Time-of-day Infusion of immunoCHemotherapy Affect Response in Oesophageal Cancer in the NeOadjuvant Setting

Completed

• Conditions: Esophagus Cancer

• Registration Number: NCT05615129
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

It is reported that compared to chemotherapy alone, immunochemotherapy has significantly improved the overall survival of patients with advanced metastatic ESCC. However, there are still more than 30% of patients who cannot benefit from this treatment modality. In addition to these factors, the time-of-day infusion and administration sequence of immunochemotherapy have been reported to be associated with tumor responses and overall survival. In this study, The investigators aimed to explore the roles of infusion time and administration sequence of immunochemotherapy in predicting tumor responses and overall survival in patients with advanced ESCC.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-08-30
• Study Completion: 2022-10-30
• Status Verified: 2022-11
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-14
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Pathologically diagnosed as esophageal squamous cell carcinoma
• KPS≥80
• Adequate organ function
• No distant metastasis
• The diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist

Exclusion Criteria

• incomplete medical record which affects statistical analysis
• have participated in previous interventional clinical trials
• other situations evaluated by investigators not meet the enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	from the date of diagnosis to the date of death, assessed up to 100 months	Overall survival rate

Secondary Outcome Measures

Name	Time	Method
Pathologic complete response rate (pCR)	Three to five working days after surgery	The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China