Esophageal CancerNCT06012318
Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
An observational study of Esophageal Cancer and Patient-reported Outcomes, run by Guangdong Provincial People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer, Patient-reported Outcomes, Immunotherapy
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Monoimmunotherapy group | Not described | |
| Chemoimmunotherapy group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and severity of adverse symptoms
Incidence and severity of adverse symptoms in esophageal cancer patients treated with immunotherapy
Measured: 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
Trajectory of adverse symptoms in esophageal cancer patients treated with immunotherapy
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start10 Sep 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Shantou University Medical College, The General Hospital of Southern Theater Command, The First Affiliated Hospital of Guangdong Pharmaceutical University, Shantou Central Hospital, Affiliated Cancer Hospital of Shantou University Medical College, Shenzhen Second People's Hospital, Longgang District People's Hospital of Shenzhen, Shenzhen Third People's Hospital, Shenzhen People's Hospital, Sichuan Cancer Hospital and Research Institute, Guangzhou Panyu Central Hospital
- Responsible party
- Principal investigator, GuiBin Qiao, Guangdong Provincial People's Hospital
- Investigators
- Guibin Qiao, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012318
- Sponsor's protocol ID
- SPRING
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
- ClinicalTrials.gov ID
- NCT06012318
- Acronym / sponsor ID
- SPRING
- Conditions
- Esophageal Cancer, Patient-reported Outcomes, Immunotherapy
- Keywords
- Esophageal Cancer, Immunotherapy, Patient-reported Outcomes, Symptom item bank
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Shantou University Medical College, The General Hospital of Southern Theater Command, The First Affiliated Hospital of Guangdong Pharmaceutical University, Shantou Central Hospital, Affiliated Cancer Hospital of Shantou University Medical College, Shenzhen Second People's Hospital, Longgang District People's Hospital of Shenzhen, Shenzhen Third People's Hospital, Shenzhen People's Hospital, Sichuan Cancer Hospital and Research Institute, Guangzhou Panyu Central Hospital
- Study start
- 10 Sep 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monoimmunotherapy group | – | – |
| Chemoimmunotherapy group | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and severity of adverse symptoms
Time frame: 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.
Incidence and severity of adverse symptoms in esophageal cancer patients treated with immunotherapy
1 secondary outcome
Trajectory of adverse symptoms
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guibin Qiao, MD principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Patient-reported Outcomes, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guibin Qiao, MD (13602749153, guibinqiao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and severity of adverse symptoms (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.