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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05615129
Other study ID # RICE-Chronos
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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