Esophageal Squamous Cell CarcinomaNCT06125262
Trajectory Analysis of NLR and Its Association With Efficacy of Immunochemotherapy in ESCC.
An observational study of Esophageal Squamous Cell Carcinoma and Immunotherapy, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Conduct a retrospective and prospective study to confirm the association between blood cells counts and the efficacy and safety in immunochemotherapy in patients with advanced esophageal cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Immunotherapy, Chemotherapy
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Jul 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who underwent neoadjuvant immunochemotherapy at Guangdong provincial peoples hospital and The First Affiliated Hospital of Shantou University.
Who may be able to join
- Pathologically confirmed esophageal squamous cell carcinoma
- Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4a N1-2 M0, cT3-T4a N0M0)
- Treatment-naive
- Expected life span > 6 months
- Aged 18 - 75 years old
- Adequate organ functions
- Performance Status (PS) 0-2
- Participants are fully informed about the whole study and are willing to sign the informed consent
Who cannot join
- Previous history of thoracic surgery or radiation
- Cervical or multi-origin esophageal cancer
- Known or suspected experimental drug allergy
- Pregnant or lactating women
- Esophagomediastinal fistula
- Peripheral neuropathy
Show all 13Show fewer
- Previous cancer history other than esophageal cancer
- Severe organ function deterioration that can not tolerate neoadjuvant therapy
- Previous autoimmune diseases
- diabetic history > 10 years
- interstitial pulmonary disease, non-infectious pulmonitis
- Active type B hepatitis
- Any other conditions that may affect patients' safety and compliance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Guibin Qiao, MD, 13602749153, guibinqiao@126.com
Guibin Qiao, MD
About this study
Official title: Trajectory Analysis of Neutrophil to Lymphocyte Ratio（NLR） and Its Association With Efficacy of Immunochemotherapy in Esophageal Squamous Cell Carcinoma: A Retrospective Cohort Study
Conduct a retrospective and prospective study to confirm the association between blood cells counts and the efficacy and safety in immunochemotherapy in patients with advanced esophageal cancer.
Read the detailed description
Studies have already demonstrated the feasibility of prognostic role of protein biomarkers change during the treatment trajectory of patients in several carcinoma,However, no study focused on the value of trajectory analysis of blood cells counts of Immunochemotherapy in patients with advanced esophageal cancer.
The investigators plan to analyze the dynamic change of blood cells counts longitudinally from preoperation to long term follow-up in advanced esophageal cancer and predict the efficacy and safety of immunochemotherapy.
- Keywords
- Advanced Esophageal Carcinoma, Immunochemotherapy, Trajectory analysis, Blood cell counts
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival and disease-free survival.
Overall survival rate
Measured: From the date of diagnosis to the date of death, assessed up to 100 months
Secondary outcomes (4)
Pathologic complete response rate
The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery
Measured: Three to five working days after surgery
Objective Response Rate (ORR)
Immune-modified Response Evaluation Criteria In SolidTumors (iRECIST) criteria defined complete response and partial response
Measured: Up to 24 weeks
Major pathological response
ess than 10% residual viable tumor follow neoadjuvant therapy
Measured: Three to five working days after surgery
Event-free survival
Event-free survival (EFS)
Measured: From the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Nov 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT06125262
- Sponsor's protocol ID
- RICE-Circulation
- Status last verified
- Dec 2023
- First submitted
- 5 Nov 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectory Analysis of Neutrophil to Lymphocyte Ratio（NLR） and Its Association With Efficacy of Immunochemotherapy in Esophageal Squamous Cell Carcinoma: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06125262
- Acronym / sponsor ID
- RICE-Circulation
- Keywords
- Advanced Esophageal Carcinoma, Immunochemotherapy, Trajectory analysis, Blood cell counts
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 9 Nov 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.
Conduct a retrospective and prospective study to confirm the association between blood cells counts and the efficacy and safety in immunochemotherapy in patients with advanced esophageal cancer.
Detailed description
Studies have already demonstrated the feasibility of prognostic role of protein biomarkers change during the treatment trajectory of patients in several carcinoma,However, no study focused on the value of trajectory analysis of blood cells counts of Immunochemotherapy in patients with advanced esophageal cancer.
The investigators plan to analyze the dynamic change of blood cells counts longitudinally from preoperation to long term follow-up in advanced esophageal cancer and predict the efficacy and safety of immunochemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent neoadjuvant immunochemotherapy at Guangdong provincial peoples hospital and The First Affiliated Hospital of Shantou University.
Key inclusion criteria (8 listed)
- Pathologically confirmed esophageal squamous cell carcinoma
- Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4a N1-2 M0, cT3-T4a N0M0)
- Treatment-naive
- Expected life span > 6 months
- Aged 18 - 75 years old
Key exclusion criteria (13 listed)
- Previous history of thoracic surgery or radiation
- Cervical or multi-origin esophageal cancer
- Known or suspected experimental drug allergy
- Pregnant or lactating women
- Esophagomediastinal fistula
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
Overall survival and disease-free survival.
Time frame: From the date of diagnosis to the date of death, assessed up to 100 months
Overall survival rate
4 secondary outcomes
Pathologic complete response rate
Time frame: Three to five working days after surgery
Objective Response Rate (ORR)
Time frame: Up to 24 weeks
Major pathological response
Time frame: Three to five working days after surgery
Event-free survival
Time frame: From the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
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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 Squamous Cell Carcinoma and Immunotherapy, 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 8 inclusion and 13 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 28 Dec 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?
Overall survival and disease-free survival. (time frame: From the date of diagnosis to the date of death, assessed up to 100 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 28 Dec 2023.