Non Small Cell Lung CancerNCT06629714
Impact of Pretreatment Emotional Distress on Survival and the Predictive Role of Peripheral Biomarkers in Immunotherapy Response Among Gastroesophageal and Lung Cancer Patients
An observational study of Non Small Cell Lung Cancer and Immune Checkpoint Inhibitors, run by Anhui Medical University at 1 site in China.
Trial summary
This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Immune Checkpoint Inhibitors, Inflammation
- What is being tested?
- Exposure: emotional distress status
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2020to 20 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort 1 comprises patients diagnosed with treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC), encompassing those with esophageal cancer, gastric cancer, and gastroesophageal junction cancer who are undergoing first-line ICI therapy. Cohort 2 consists of patients with treatment-naïve, advanced and inoperable Non-Small Cell Lung Cancer (NSCLC) receiving first-line ICI therapy.
Who may be able to join
- Meet the diagnostic criteria for cancer (including esophageal, gastric, GEJ or NSCLC) through clinical, pathological, and imaging examinations;
- Karnofsky Performance Status (KPS) score should be equal to or greater than 80 points;
- Unresectable locally advanced or metastatic;
- Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy);
- Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1);
- Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
Show all 9Show fewer
- Informed and agreed to participate in the study;
- Required to complete the questionnaire independently or with assistance from others if needed;
- Legal age, 18 years or older.
Who cannot join
- Oncogene-driver positive;
- Combined with other malignant tumors in the past 3 years;
- Concurrent acute or chronic psychiatric disorders;
- Current receiving anti-depressive or anti-anxiety therapy or other psychotropic drugs;
- Previous treatment with other clinical drug trials;
- Patients with symptomatic brain metastasis;
- Severe intellectual disabilities or other communication difficulties that hindered normal interaction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cohort Studies of Impact of Pretreatment Emotional on Survival and the Predictive Role of Peripheral Blood Metabolic and Inflammatory Markers in Immunotherapy Response Among Treatment-Naïve, Advanced and Inoperable Gastroesophageal and Non-Small-Cell Lung Cancer Patients
This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and non-small-cell lung cancer (NSCLC).
Read the detailed description
This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and Non-Small-Cell Lung Cancer (NSCLC). Eligible patients were administered first-line treatment with either immune checkpoint inhibitor or a combination of immunotherapy and chemotherapy upon enrollment. This study will have 2 cohorts:
- Cohort 1: A prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable GEC patients.
- Cohort 2: A prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable NSCLC patients.
- Conditions
- Non Small Cell Lung Cancer, Immune Checkpoint Inhibitors, Inflammation, Cancer, Treatment-Related, Emotional Distress, Gastroesophageal Cancer (GC)
- Being tested
- Exposure: emotional distress status
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Inflammation, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure: emotional distress statusOther
The assessment of depressive and anxiety symptoms was conducted using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment 7 (GAD-7). Patients with a sum score of PHQ-9 and GAD-7 ≥ 10 were categorized as the stressed group.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Treatment-naïve, advanced and inoperable GEC patients receiving first-line ICIs | For treatment-naïve, advanced and inoperable Esophageal Cancer or Gastric Cancer or Gastroesophageal junction (GEJ) Cancer patients who have received immune checkpoint inhibitors as first-line therapy. Receives: Other: Exposure: emotional distress status | |
| Cohort 2: Treatment-naïve, advanced and inoperable NSCLC patients receiving first-line ICIs. | For treatment-naïve, advanced and inoperable Non-Small-Cell Lung Cancer patients who have received immune checkpoint inhibitors as first-line therapy. Receives: Other: Exposure: emotional distress status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1 & 2: Progression-free survival (PFS)
Time from the beginning of first-line immunotherapy to the first progression (PD) or death in patients
Measured: 4 year
Secondary outcomes (12)
Value of Neutrophils to lymphocytes ratio (NLR)
NLR is an inflammatory marker, which is the ratio of neutrophils to lymphocytes. The higher the value is, the higher the inflammatory level may be. The information has been extracted from the medical record and evaluated longitudinally.
Measured: 0 day, 6 weeks
Value of Platelet-lymphocyte ratio (PLR)
PLR is an inflammatory marker, a ratio of platelets to lymphocytes. A higher value of it indicates a higher level of inflammation in the body. The information has been extracted from the medical record and evaluated longitudinally.
Measured: 0 day, 6 weeks
Value of Monocyte-lymphocyte ratio (MLR)
MLR is an inflammatory indicator, which is the ratio of macrophages and lymphocytes. The higher the value is, the higher the inflammatory level in the body is. The information has been extracted from the medical record and evaluated longitudinally.
Measured: 0 day, 6 weeks
Value of Systemic immune inflammation index (SII)
SII is an inflammatory indicator, which is calculated as follows: SII= (neutrophil × platelet)/lymphocytes. A higher value indicates an elevated level of inflammation within the body. The information has been extracted from the medical record and evaluated longitudinally.
Measured: 0 day, 6 weeks
Value of Pan-immune inflammation value (PIV)
PIV is an inflammatory indicator, which is equal to neutrophils × monocytes × platelets/lymphocytes. The higher the value is, the higher the inflammatory level in the body is. The information has been extracted from the medical record and evaluated longitudinally.
Measured: 0 day, 6 weeks
Value of eosinophil fraction
The eosinophil fraction is a potential inflammation and tumor prognostic indicator, which equals the ratio of eosinophil absolute value to the total white blood cell count. The higher the value of this fraction, the better the tumor prognosis may be. The information has been extracted from the medical record and evaluated longitudinally.
Measured: 0 day, 6 weeks
Value of prognostic nutritional index (PNI)
PNI is a potential inflammation and tumor prognostic indicator, which is equal to albumin level (g/L) + 5 × absolute value of lymphocyte counts. The higher the value of this index, the better the tumor prognosis may be. The information has been extracted from the medical record and evaluated longitudinally.
Measured: 0 day, 6 weeks
Value of Blood glucose
Blood glucose is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally.
Measured: 0 day, 6 weeks
Value of Triglycerides
Triglycerides is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally.
Measured: 0 day, 6 weeks
Value of Total cholesterol
Total cholesterol is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally.
Measured: 0 day, 6 weeks
Value of Albumin
Albumin is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally.
Measured: 0 day, 6 weeks
Disease Control Rate (DCR)
DCR refers to the proportion of patients with tumor treated with a certain treatment who have tumor shrinkage or stable disease, and this state can be maintained for a certain period of time, including the proportion of Complete Response (CR), Partial Response (PR) and Stable Disease (SD).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start16 Oct 2020
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huaidong Cheng, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629714
- Sponsor's protocol ID
- 83242393
- Status last verified
- Jan 2026
- First submitted
- 4 Oct 2024
- Last updated
- 13 Jan 2026
- 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Studies of Impact of Pretreatment Emotional on Survival and the Predictive Role of Peripheral Blood Metabolic and Inflammatory Markers in Immunotherapy Response Among Treatment-Naïve, Advanced and Inoperable Gastroesophageal and Non-Small-Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT06629714
- Acronym / sponsor ID
- 83242393
- Conditions
- Non Small Cell Lung Cancer, Immune Checkpoint Inhibitors, Inflammation, Cancer, Treatment-Related, Emotional Distress, Gastroesophageal Cancer (GC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 8 Oct 2024 (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.
This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and non-small-cell lung cancer (NSCLC).
Detailed description
This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and Non-Small-Cell Lung Cancer (NSCLC). Eligible patients were administered first-line treatment with either immune checkpoint inhibitor or a combination of immunotherapy and chemotherapy upon enrollment. This study will have 2 cohorts:
- Cohort 1: A prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable GEC patients.
- Cohort 2: A prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable NSCLC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Treatment-naïve, advanced and inoperable GEC patients receiving first-line ICIs | – | Other: Exposure: emotional distress statusFor treatment-naïve, advanced and inoperable Esophageal Cancer or Gastric Cancer or Gastroesophageal junction (GEJ) Cancer patients who have received immune checkpoint inhibitors as first-line therapy. |
| Cohort 2: Treatment-naïve, advanced and inoperable NSCLC patients receiving first-line ICIs. | – | Other: Exposure: emotional distress statusFor treatment-naïve, advanced and inoperable Non-Small-Cell Lung Cancer patients who have received immune checkpoint inhibitors as first-line therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort 1 comprises patients diagnosed with treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC), encompassing those with esophageal cancer, gastric cancer, and gastroesophageal junction cancer who are undergoing first-line ICI therapy. Cohort 2 consists of patients with treatment-naïve, advanced and inoperable Non-Small Cell Lung Cancer (NSCLC) receiving first-line ICI therapy.
Key inclusion criteria (9 listed)
- Meet the diagnostic criteria for cancer (including esophageal, gastric, GEJ or NSCLC) through clinical, pathological, and imaging examinations;
- Karnofsky Performance Status (KPS) score should be equal to or greater than 80 points;
- Unresectable locally advanced or metastatic;
- Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy);
- Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1);
Key exclusion criteria (7 listed)
- Oncogene-driver positive;
- Combined with other malignant tumors in the past 3 years;
- Concurrent acute or chronic psychiatric disorders;
- Current receiving anti-depressive or anti-anxiety therapy or other psychotropic drugs;
- Previous treatment with other clinical drug trials;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure: emotional distress statusThe assessment of depressive and anxiety symptoms was conducted using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment 7 (GAD-7). Patients with a sum score of PHQ-9 and GAD-7 ≥ 10 were categorized as the stressed group. | Other | Cohort 1: Treatment-naïve, advanced and inoperable GEC patients receiving first-line ICIs, Cohort 2: Treatment-naïve, advanced and inoperable NSCLC patients receiving first-line ICIs. |
Primary outcome
Cohort 1 & 2: Progression-free survival (PFS)
Time frame: 4 year
Time from the beginning of first-line immunotherapy to the first progression (PD) or death in patients
12 secondary outcomes
Value of Neutrophils to lymphocytes ratio (NLR)
Time frame: 0 day, 6 weeks
Value of Platelet-lymphocyte ratio (PLR)
Time frame: 0 day, 6 weeks
Value of Monocyte-lymphocyte ratio (MLR)
Time frame: 0 day, 6 weeks
Value of Systemic immune inflammation index (SII)
Time frame: 0 day, 6 weeks
Value of Pan-immune inflammation value (PIV)
Time frame: 0 day, 6 weeks
Value of eosinophil fraction
Time frame: 0 day, 6 weeks
Value of prognostic nutritional index (PNI)
Time frame: 0 day, 6 weeks
Value of Blood glucose
Time frame: 0 day, 6 weeks
Value of Triglycerides
Time frame: 0 day, 6 weeks
Value of Total cholesterol
Time frame: 0 day, 6 weeks
Value of Albumin
Time frame: 0 day, 6 weeks
Disease Control Rate (DCR)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Non Small Cell Lung Cancer and Immune Checkpoint Inhibitors, run by Anhui 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 9 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: finished, as of the sponsor's last update on 13 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1 & 2: Progression-free survival (PFS) (time frame: 4 year). 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 13 Jan 2026.