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

NCT06012318 | Unknown DMC

• 1 other identifier: SPRING
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Esophageal Cancer; Patient-reported Outcomes; Immunotherapy

Keywords

Esophageal Cancer; Immunotherapy; Patient-reported Outcomes; Symptom item bank

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Trajectory of adverse symptoms

  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.

Study Arms (2)

Monoimmunotherapy group

Chemoimmunotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population of the study is patients with esophageal cancer who have received or are receiving immunotherapy-based regimens in various stages, including resectable, locally advanced, and advanced stages.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

• Guibin Qiao, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guibin Qiao, MD

CONTACT

13602749153; guibinqiao@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 25, 2023
• Study Start: September 10, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 31, 2024
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)