Esophageal Squamous Cell CarcinomaNCT05392413
Immune Indicator Model for Predicting Efficacy of PD-1 Monoclonal Antibody
An observational study of Esophageal Squamous Cell Carcinoma and PD-1 Inhibitor, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
200 patients with advanced esophageal cancer who received PD-1 monoclonal antibody treatment would be enrolled in this study. Changes in peripheral blood immune cells before and after treatment would be recorded and used for machine learning to establish a prediction model for the efficacy of PD-1 monoclonal antibody… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, PD-1 Inhibitor
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients with advanced esophageal cell carcinoma who are ready to receive PD-1 monoclonal antibody therpy
Who may be able to join
- Patients with metastatic advanced esophageal squamous cell carcinoma (stage IV) confirmed by histology or cytology who are ready to receive PD-1 monoclonal antibody combined with TP chemotherapy regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2.
- Have measurable lesions.
- Expected survival > 3 months.
- Subjects who have received anti-tumor therapy in the past should be enrolled after the toxicity of the previous treatment has returned to the baseline level (except for residual hair loss effects) or CTCAE v4.03 scale score ≤ 1.
- Female or male subjects of reproductive age and their partners should agree to use effective contraception from the time of signing the ICF until 6 months after the last dose of study drug.
- Absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥9 g/dL. Liver: Bilirubin ≤1.5 times the upper limit of normal, alkaline phosphatase (AP) , Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 times the upper limit of normal (AP, AST, ALT ≤5 times the upper limit of normal are allowed if there is liver metastases) Renal: Calculated creatinine clearance ≥45 mL/min.
Who cannot join
- Have active, or have had an autoimmune disease that is likely to recur (eg, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.) or at risk (e.g., organ transplant recipients requiring immunosuppressive therapy).
- Subjects who need to receive glucocorticoid (prednisone > 10 mg/day or equivalent dose of other similar drugs) or other immunosuppressive therapy due to certain conditions within 14 days prior to study drug administration.
- Major surgery, or radical radiation therapy, or palliative radiation therapy within the previous 14 days, or radiopharmaceuticals (strontium, samarium, etc.) within 56 days before starting study treatment.
- Received systemic anti-tumor therapy, including immunotherapy, biological therapy (tumor vaccines, cytokines, or growth factors to control cancer), etc. 14 days before starting study treatment.
- Have suffered from interstitial lung disease, chemical pneumonia, hypersensitivity pneumonitis, connective tissue disease pneumonia, pulmonary fibrosis, acute lung disease, etc. (except for local interstitial pneumonia induced by radiotherapy), or uncontrolled systemic disease, including diabetes and hypertension.
- Patients with human immunodeficiency virus (HIV) infection.
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- patients with active pulmonary tuberculosis.
- Any active infection requiring systemic therapy by intravenous infusion within 2 weeks prior to the first dose of study drug.
- People who have received a solid organ transplant.
- Patients who have received any antibody/drug (including anti-programmed death-1 (PD-1), PD-L1, etc.) targeting T-cell co-regulatory proteins (immune checkpoints).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Construction and Application of Immune Indicator Model for Predicting Efficacy of PD-1 Monoclonal Antibody in the Treatment of Advanced Esophageal Cancer
200 patients with advanced esophageal cancer who received PD-1 monoclonal antibody treatment would be enrolled in this study. Changes in peripheral blood immune cells before and after treatment would be recorded and used for machine learning to establish a prediction model for the efficacy of PD-1 monoclonal antibody treatment.
Read the detailed description
PD-1 monoclonal antibody has been used as a first-line drug for the treatment of advanced esophageal cancer, however, the ideal predictor of efficacy has not been established. The peripheral immune system plays an important role in driving anti-tumor effects, and the characteristics of peripheral immune cells can predict the effect of PD-1 monoclonal antibody therapy. However, the value of a single indicator for predicting the effect of PD-1 monoclonal antibody therapy is greatly limited. 200 patients with advanced esophageal cancer who received PD-1 monoclonal antibody treatment would be enrolled. Changes in peripheral blood immune cells before and after treatment would be recorded and used for machine learning to establish a prediction model for the efficacy of PD-1 monoclonal antibody treatment. The application between the indicator model and the expression level of PD-L1 in tumor tissue in predicting the efficacy of PD-1 monoclonal antibody in advanced esophageal cancer will be also study. This study aims to establish a peripheral blood immune cell-based models to predict the efficacy of PD-1 monoclonal antibody therapy for advanced esophageal cancer, provide a basis for guiding the selection of treatment options for advanced esophageal cancer, and improve the efficacy of PD-1 monoclonal antibody therapy.
- Conditions
- Esophageal Squamous Cell Carcinoma, PD-1 Inhibitor
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
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 |
|---|---|---|
| reactive group | According to the treatment effect, the patients were divided into two groups: reactive and non-reactive. | |
| non-reactive group | According to the treatment effect, the patients were divided into two groups: reactive and non-reactive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
peripheral blood immune cells and immune molecules
Including absolute count of lymphocyte subsets, T lymphocyte subsets, B lymphocyte subsets, NK cell subsets, regulatory T cells, MDSC, etc. and IL-6, IL-10, etc.
Measured: 2022.1-2026.12
Imaging examination
Including X-rays, CT, PET-CT and MR
Measured: 2022.1-2026.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (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 Nanfang Hospital, Southern Medical UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Zheng, Study director, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392413
- Sponsor's protocol ID
- NFEC-2022-079
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of Immune Indicator Model for Predicting Efficacy of PD-1 Monoclonal Antibody in the Treatment of Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05392413
- Acronym / sponsor ID
- NFEC-2022-079
- Conditions
- Esophageal Squamous Cell Carcinoma, PD-1 Inhibitor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 May 2022 (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.
200 patients with advanced esophageal cancer who received PD-1 monoclonal antibody treatment would be enrolled in this study. Changes in peripheral blood immune cells before and after treatment would be recorded and used for machine learning to establish a prediction model for the efficacy of PD-1 monoclonal antibody treatment.
Detailed description
PD-1 monoclonal antibody has been used as a first-line drug for the treatment of advanced esophageal cancer, however, the ideal predictor of efficacy has not been established. The peripheral immune system plays an important role in driving anti-tumor effects, and the characteristics of peripheral immune cells can predict the effect of PD-1 monoclonal antibody therapy. However, the value of a single indicator for predicting the effect of PD-1 monoclonal antibody therapy is greatly limited. 200 patients with advanced esophageal cancer who received PD-1 monoclonal antibody treatment would be enrolled. Changes in peripheral blood immune cells before and after treatment would be recorded and used for machine learning to establish a prediction model for the efficacy of PD-1 monoclonal antibody treatment. The application between the indicator model and the expression level of PD-L1 in tumor tissue in predicting the efficacy of PD-1 monoclonal antibody in advanced esophageal cancer will be also study. This study aims to establish a peripheral blood immune cell-based models to predict the efficacy of PD-1 monoclonal antibody therapy for advanced esophageal cancer, provide a basis for guiding the selection of treatment options for advanced esophageal cancer, and improve the efficacy of PD-1 monoclonal antibody therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reactive group | – | –According to the treatment effect, the patients were divided into two groups: reactive and non-reactive. |
| non-reactive group | – | –According to the treatment effect, the patients were divided into two groups: reactive and non-reactive. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced esophageal cell carcinoma who are ready to receive PD-1 monoclonal antibody therpy
Key inclusion criteria (7 listed)
- Patients with metastatic advanced esophageal squamous cell carcinoma (stage IV) confirmed by histology or cytology who are ready to receive PD-1 monoclonal antibody combined with TP chemotherapy regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2.
- Have measurable lesions.
- Expected survival > 3 months.
- Subjects who have received anti-tumor therapy in the past should be enrolled after the toxicity of the previous treatment has returned to the baseline level (except for residual hair loss effects) or CTCAE v4.03 scale score ≤ 1.
Key exclusion criteria (10 listed)
- Have active, or have had an autoimmune disease that is likely to recur (eg, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.) or at risk (e.g., organ transplant recipients requiring immunosuppressive therapy).
- Subjects who need to receive glucocorticoid (prednisone > 10 mg/day or equivalent dose of other similar drugs) or other immunosuppressive therapy due to certain conditions within 14 days prior to study drug administration.
- Major surgery, or radical radiation therapy, or palliative radiation therapy within the previous 14 days, or radiopharmaceuticals (strontium, samarium, etc.) within 56 days before starting study treatment.
- Received systemic anti-tumor therapy, including immunotherapy, biological therapy (tumor vaccines, cytokines, or growth factors to control cancer), etc. 14 days before starting study treatment.
- Have suffered from interstitial lung disease, chemical pneumonia, hypersensitivity pneumonitis, connective tissue disease pneumonia, pulmonary fibrosis, acute lung disease, etc. (except for local interstitial pneumonia induced by radiotherapy), or uncontrolled systemic disease, including diabetes and hypertension.
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
peripheral blood immune cells and immune molecules
Time frame: 2022.1-2026.12
Including absolute count of lymphocyte subsets, T lymphocyte subsets, B lymphocyte subsets, NK cell subsets, regulatory T cells, MDSC, etc. and IL-6, IL-10, etc.
Imaging examination
Time frame: 2022.1-2026.12
Including X-rays, CT, PET-CT and MR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- 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.
Lei Zheng study director
Nanfang Hospital, Southern Medical University
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 PD-1 Inhibitor, run by Nanfang Hospital, Southern Medical University 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 10 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: looking for participants now, as of the sponsor's last update on 6 Jul 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuai Chu (18665000310, shine9533@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peripheral blood immune cells and immune molecules (time frame: 2022.1-2026.12). 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 6 Jul 2022.