Status:
UNKNOWN
Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
Lead Sponsor:
Guangdong Provincial People's Hospital
Collaborating Sponsors:
First Affiliated Hospital of Shantou University Medical College
The General Hospital of Southern Theater Command
Conditions:
Esophageal Cancer
Patient-reported Outcomes
Eligibility:
All Genders
18-75 years
Brief Summary
Immunotherapy shows satisfactory effectiveness and safety in patients with esophageal cancer. Immunotherapy-based regimens have a better survival benefit compared to previous chemotherapy and radiothe...
Eligibility Criteria
Inclusion
- Pathologically confirmed resectable, locally advanced, advanced metastatic esophageal cancer
- Having received or undergoing an immunotherapy-based treatment regimen
- Age 18-75 years
- ECOG PS of 0-2
- Adequate organ function
- Life expectancy \> 6 months
- Participants are fully informed about the whole study and are willing to sign the informed consent
Exclusion
- Absence of immunotherapy regimen, or recieving radiotherapy.
- Presence of primary tumours elsewhere, such as gastric cancer, lung cancer or cervical cancer
- Severe organ function deterioration and intolerance to immunotherapy
- Pregnant or breast-feeding women
- Previous autoimmune disease
- Any other conditions that may affect patients' safety and compliance
- Psychological, family, social and other factors leading to inability to inform consent
Key Trial Info
Start Date :
September 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06012318
Start Date
September 10 2023
End Date
December 31 2024
Last Update
August 25 2023
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080