Esophagus Cancer Clinical Trial
— RICE-ChronosOfficial title:
Effect of Immunochemotherapy Sequence and Time-of-day Infusion on Efficacy and Prognosis of Patients With Advanced Esophageal Squamous Cell Carcinoma
Verified date | November 2022 |
Source | Guangdong Provincial People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Guangdong Provincial People's Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangdong Provincial People's Hospital | Peking University Shenzhen Hospital, The First Affiliated Hospital of Shantou Univesity Medical College |
China,
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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