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OpenTrials
Completed

NCT Number: NCT05615129

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

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.

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Key information

Conditions

Esophagus Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival

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

    Overall survival rate

Secondary outcomes

  1. Pathologic complete response rate (pCR)

    Time frame: Three to five working days after surgery

    The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Collaborators

  • First Affiliated Hospital of Shantou University Medical College
  • Peking University Shenzhen Hospital

Registry information

Official study title

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

Acronym: RICE-Chronos

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 14, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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