Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)

Esophageal Cancer Clinical Trial

Official title:

Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06012318
• Other study ID #: SPRING
• Status: Not yet recruiting
• Start date: September 10, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Guangdong Provincial People's Hospital
• Contact: Guibin Qiao, MD
• Phone: 13602749153
• Email: guibinqiao[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 radiotherapy. Patient-reported outcomes (PRO) provide a reliable assessment of patients' functional status during treatment. However, the spectrum of symptoms in esophageal cancer patients receiving immunotherapy is uncertain, and there are no studies applying the symptom bank based on PRO to the immunotherapy model for esophageal cancer. In this prospective study, the investigators aimed to preliminarily screen for symptoms associated with immunotherapy for esophageal cancer through a systematic literature review and expert evaluation, and build a symptom item bank for esophageal cancer patients receiving immunotherapy. Adverse symptoms in esophageal cancer patients treated with immunotherapy were collected prospectively. The distribution and severity of the symptoms, as well as the trajectory of symptom change were further analyzed to demonstrate the validity and reliability of the symptom item bank. It would refine the spectrum of symptoms for esophageal cancer patients receiving immunotherapy and provide a foundation for assessing the specific symptom burden in patients with esophageal cancer receiving immunotherapy regimens.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 31, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Immunotherapy
• Patient-reported Outcomes

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (12)

Lead Sponsor

Collaborator

Guangdong Provincial People's Hospital

Affiliated Cancer Hospital of Shantou University Medical College, First Affiliated Hospital of Shantou University Medical College, Guangzhou Panyu Central Hospital, Longgang District Central Hospital of Shenzhen, Shantou Central Hospital, Shenzhen People's Hospital, Shenzhen Second People's Hospital, Shenzhen Third People's Hospital, Sichuan Cancer Hospital and Research Institute, The First Affiliated Hospital of Guangdong Pharmaceutical University, The General Hospital of Southern Theater Command

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence and severity of adverse symptoms	Incidence and severity of adverse symptoms in esophageal cancer patients treated with immunotherapy	Patients were evaluated from the beginning of immunochemotherapy to three weeks after completion of the last immunochemotherapy treatment. The total time for patient evaluation is less than 6 months.
Secondary	Trajectory of adverse symptoms	Trajectory of adverse symptoms in esophageal cancer patients treated with immunotherapy	Patients were evaluated from the beginning of immunochemotherapy to three weeks after completion of the last immunochemotherapy treatment. The total time for patient evaluation is less than 6 months.