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

Esophagus Cancer Clinical Trial

— RICE-Chronos  

Official title:

Effect of Immunochemotherapy Sequence and Time-of-day Infusion on Efficacy and Prognosis of Patients With Advanced Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05615129
• Other study ID #: RICE-Chronos
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: November 2022
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: October 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital	Peking University Shenzhen Hospital, The First Affiliated Hospital of Shantou Univesity Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival rate	from the date of diagnosis to the date of death, assessed up to 100 months
Secondary	Pathologic complete response rate (pCR)	The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery	Three to five working days after surgery