Esophageal Squamous Cell CarcinomaNCT04440332
Surveillance of Peripheral Blood of Lymphocyte and Immunocyte in Neoadjuvant Therapy Patients With Esophageal Squamous Cell Carcinoma (pLINE)
An observational study of Esophageal Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
Neoadjuvant chemoradiotherapy treatment represents the standard approach for resectable locally advanced esophageal squamous cell carcinoma. The incidence of pulmonary infection and other perioperative complications were higher in patients who received esophagectomy and neoadjuvant chemoradiotherapy than those without… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy, Surgery
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 31 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with esophageal squamous cell carcinoma who accept esophagectomy alone or neoadjuvant chemoradiotherapy treatment followed by surgery are acceptable.
Who may be able to join
- 1. Histologically confirmed locally advanced resectable thoracic ESCC; and requires esophagectomy alone or neoadjuvant chemoradiotherapy combined surgery treatment; Clinical stage T1-3N2-3M0 (AJCC 8 TNM classification);
- 2. At least one measurable lesion in accordance with RECIST 1.1;
- 3. Have a performance status of 0 or 1 on the ECOG Performance Scale;
- 4. Expected survival time is greater than 6 months;
- 5. Good organ function level: Hematology: white blood cell ≥3×10^9/L, neutrophil ≥1.5×10^9/L, hemoglobin ≥90 g/L and platelet ≥100×10^9/L; hepatic function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN), or total bilirubin > ULN, but direct bilirubin ≤ULN, ALT, AST ≤2.5 times the upper limit of normal value; Renal function: serum creatinine ≤1.5 times of ULN; Coagulation function: international normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 x ULN;
- 6. The electrocardiograph was generally normal, and the left ventricular ejection fraction (LVEF) was ≥50%, Or the myocardial enzyme spectrum is in the normal range;
Show all 9Show fewer
- 7. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) in the normal range; If baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 in the normal range will also be enrolled;
- 8. Female subjects of childbearing potential have a negative pregnancy test and must agree to take effective contraceptive measures during the study period and within 3 months after the last dose;
- 9. Be willing and able to provide written informed consent/assent for the trial.
Who cannot join
- 1. Patients with possible tracheoesophageal fistula or aortic esophageal fistula;
- 2. Patients with active autoimmune disease or documented autoimmune disease or symptoms requiring systemic hormone therapy or anti-autoimmune drug therapy;
- 3. Patients with immunodeficiency or who were still receiving systemic steroid hormone therapy (prednisone > 10 mg/ day or other equivalent drugs) or other forms of immunosuppressive therapy 7 days prior to the first dose of neoadjuvant therapy in this study;
- 4. Received anti-tumor therapy, including but not limited to chemotherapy, radiotherapy, immunotherapy, and targeted therapy, within 28 days prior to initial administration;
- 5. Patients with active infection who still required systemic treatment 7 days before the first dose of neoadjuvant therapy in this study;
- 6. Uncontrolled brain metastases;
Show all 18Show fewer
- 7. Patients with interstitial lung disease, non-infectious pneumonia, or pulmonary fibrosis;
- 8. Patients with active tuberculosis (TB), who is receiving anti-TB treatment or who has received anti-TB treatment within 1 year before the first drug use
- 9. Patients with uncontrolled diabetes (fasting blood glucose ≥CTCAE level 2);
- 10. Peripheral neuropathy of degree II or above was found within 4 weeks before enrollment;
- 11.Patients who have received a foreign organ or stem cell transplant in the past;
- 12. Patients with allergies to the drugs or related ingredients in this study;
- 13. Patients with any serious or unstable medical condition or mental illness;
- 14. History of drug abuse or dependence;
- 15. Major organ disorders or diseases: liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis, etc;
- 16. History of other malignancies within 5 years (except for cured cervical cancer or basal cell carcinoma of the skin);
- 17. Patients who also participated in other clinical trials;
- 18. The researchers did not consider the patients suitable for any medical condition under study.
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041
Xue-Feng Leng, M.D., Ph.D., +86 18702870755, leng724@163.com
About this study
Official title: The Clinical Significance of Surveillance of Lymphocyte and Immunocyte Subsets in Peripheral Blood of Esophageal Squamous Cell Carcinoma Patients With Neoadjuvant Chemoradiotherapy Combine Surgery or Surgery Alone (pLINE）.
Neoadjuvant chemoradiotherapy treatment represents the standard approach for resectable locally advanced esophageal squamous cell carcinoma. The incidence of pulmonary infection and other perioperative complications were higher in patients who received esophagectomy and neoadjuvant chemoradiotherapy than those without neoadjuvant treatment and surgery patients. However, reliable clinical data can quantify the damage degree of immunologic function caused by chemotherapy and radiotherapy is still unknown. This project regards the level of lymphocyte and immunocyte in peripheral blood as a quantitative index to reflect the dynamic change of the immunologic function of patients with locally advanced esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy treatment. Meanwhile, the investigators will also investigate the relationship between the level of lymphocyte and immunocyte in peripheral blood and the response rate of neoadjuvant therapy.
Read the detailed description
Peripheral blood will be collected from patients who will undergo esophagectomy and/or neoadjuvant therapy. The setting time is before chemoradiotherapy, finishing chemoradiotherapy, pre-operation, postoperative day 1, day 3, day 5, and day 7. These blood samples will be used for detection and analysis in lymphocyte and immunocyte by flow cytometry.
- Keywords
- esophageal squamous cell carcinoma, lymphocyte subsets, neoadjuvant chemoradiotherapy, immunocyte
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete pathologic response rate and its relationship between peripheral blood of lymphocyte and immunocyte.
Definition of complete pathologic response is "no cancer cell, including lympho nodes".
Measured: 3 months
Postoperative pulmonary infection rate and its relationship between peripheral blood of lymphocyte and immunocyte.
The pulmonary infection after surgery included bacterial pneumonia and viral pneumonia and fungal pneumonia.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (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.
- 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
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongtao Han, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440332
- Sponsor's protocol ID
- 3001
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 19 Jun 2020
- 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 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Significance of Surveillance of Lymphocyte and Immunocyte Subsets in Peripheral Blood of Esophageal Squamous Cell Carcinoma Patients With Neoadjuvant Chemoradiotherapy Combine Surgery or Surgery Alone (pLINE）.
- ClinicalTrials.gov ID
- NCT04440332
- Acronym / sponsor ID
- 3001
- Keywords
- esophageal squamous cell carcinoma, lymphocyte subsets, neoadjuvant chemoradiotherapy, immunocyte
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Jun 2020 (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.
Neoadjuvant chemoradiotherapy treatment represents the standard approach for resectable locally advanced esophageal squamous cell carcinoma. The incidence of pulmonary infection and other perioperative complications were higher in patients who received esophagectomy and neoadjuvant chemoradiotherapy than those without neoadjuvant treatment and surgery patients. However, reliable clinical data can quantify the damage degree of immunologic function caused by chemotherapy and radiotherapy is still unknown. This project regards the level of lymphocyte and immunocyte in peripheral blood as a quantitative index to reflect the dynamic change of the immunologic function of patients with locally advanced esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy treatment. Meanwhile, the investigators will also investigate the relationship between the level of lymphocyte and immunocyte in peripheral blood and the response rate of neoadjuvant therapy.
Detailed description
Peripheral blood will be collected from patients who will undergo esophagectomy and/or neoadjuvant therapy. The setting time is before chemoradiotherapy, finishing chemoradiotherapy, pre-operation, postoperative day 1, day 3, day 5, and day 7. These blood samples will be used for detection and analysis in lymphocyte and immunocyte by flow cytometry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with esophageal squamous cell carcinoma who accept esophagectomy alone or neoadjuvant chemoradiotherapy treatment followed by surgery are acceptable.
Key inclusion criteria (9 listed)
- 1. Histologically confirmed locally advanced resectable thoracic ESCC; and requires esophagectomy alone or neoadjuvant chemoradiotherapy combined surgery treatment; Clinical stage T1-3N2-3M0 (AJCC 8 TNM classification);
- 2. At least one measurable lesion in accordance with RECIST 1.1;
- 3. Have a performance status of 0 or 1 on the ECOG Performance Scale;
- 4. Expected survival time is greater than 6 months;
- 5. Good organ function level: Hematology: white blood cell ≥3×10^9/L, neutrophil ≥1.5×10^9/L, hemoglobin ≥90 g/L and platelet ≥100×10^9/L; hepatic function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN), or total bilirubin > ULN, but direct bilirubin ≤ULN, ALT, AST ≤2.5 times the upper limit of normal value; Renal function: serum creatinine ≤1.5 times of ULN; Coagulation function: international normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 x ULN;
Key exclusion criteria (18 listed)
- 1. Patients with possible tracheoesophageal fistula or aortic esophageal fistula;
- 2. Patients with active autoimmune disease or documented autoimmune disease or symptoms requiring systemic hormone therapy or anti-autoimmune drug therapy;
- 3. Patients with immunodeficiency or who were still receiving systemic steroid hormone therapy (prednisone > 10 mg/ day or other equivalent drugs) or other forms of immunosuppressive therapy 7 days prior to the first dose of neoadjuvant therapy in this study;
- 4. Received anti-tumor therapy, including but not limited to chemotherapy, radiotherapy, immunotherapy, and targeted therapy, within 28 days prior to initial administration;
- 5. Patients with active infection who still required systemic treatment 7 days before the first dose of neoadjuvant therapy in this study;
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
Complete pathologic response rate and its relationship between peripheral blood of lymphocyte and immunocyte.
Time frame: 3 months
Definition of complete pathologic response is "no cancer cell, including lympho nodes".
Postoperative pulmonary infection rate and its relationship between peripheral blood of lymphocyte and immunocyte.
Time frame: 3 months
The pulmonary infection after surgery included bacterial pneumonia and viral pneumonia and fungal pneumonia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
Related trials for Esophageal Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Recruiting
Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial
Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
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.
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 Neoadjuvant Therapy, run by Sichuan Cancer Hospital and Research Institute 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 9 inclusion and 18 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 19 Jun 2020. 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 Xue-Feng Leng, M.D., Ph.D. (+86 18702870755, leng724@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete pathologic response rate and its relationship between peripheral blood of lymphocyte and immunocyte. (time frame: 3 months). The study lists 2 primary outcomes in all. 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 19 Jun 2020.