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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05615129
Acronym
RICE-Chronos
Enrollment
350
Registered
2022-11-14
Start date
2021-10-01
Completion date
2022-10-30
Last updated
2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagus Cancer

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.

Interventions

None listed

Sponsors

First Affiliated Hospital of Shantou University Medical College
CollaboratorOTHER
Peking University Shenzhen Hospital
CollaboratorOTHER
Guangdong Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survivalfrom the date of diagnosis to the date of death, assessed up to 100 monthsOverall survival rate

Secondary

MeasureTime frameDescription
Pathologic complete response rate (pCR)Three to five working days after surgeryThe rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026