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

NCT05615129 | Completed DMC

• 1 other identifier: RICE-Chronos
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagus Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival rate

  from the date of diagnosis to the date of death, assessed up to 100 months

Secondary Outcomes (1)

• Pathologic complete response rate (pCR)

  Three to five working days after surgery

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed as potentially resectable (including initially-unresectable) esophageal squamous cell carcinoma via pathological specimen, KPS ≥ 80, has adequate organ function and no distant metastasis are included in the study

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• First Affiliated Hospital of Shantou University Medical College: collaborator
• Peking University Shenzhen Hospital: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: October 1, 2021
• Primary Completion: August 30, 2022
• Study Completion: October 30, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CN (1)