Tumor MicroenvironmentNCT06230965
Clinical Study of Lung Protective Ventilation Strategies and Tumor Microenvironment
A study testing Lung protective ventilation strategy in people with Tumor Microenvironment, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
This study will be conducted in the Affiliated Hospital of Nantong University. Sixty colorectal cancer(CRC) patients are randomized into traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), there were 30 cases in each group. Read more about this study
- Who is it for?
- Ages 51 to 75 years
- Conditions the study is for
- Tumor Microenvironment
- What is being tested?
- Lung protective ventilation strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- 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 51 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologic diagnosis of Colorectal Cancer
- American society of Aneshesiologists（ASA）physical status classification system Grade Ⅱ-Ⅲ;
- From 51-70 years old with no gender restrictions
- Normal cardiopulmonary function before operation
- Body Mass Index:18-30
Who cannot join
- Preoperative anemia (hemoglobin<10g/dl)
- Patients with preoperative mechanical ventilation;
- A history of pulmonary infection and pulmonary tuberculosis within 1 month before surgery;
- Preoperative blood oxygen saturation (SpO₂) was less than 90% (SpO₂<90%), or the oxygen partial pressure (PaO₂) was less than 90% (PaO₂<60 mmHg), or PaO₂/fraction of inspired oxygen（FiO₂）ratio<300 mmHg, or arterial blood carbon dioxide partial pressure (PaCO₂) was greater than 45 mmHg (PaCO₂>45 mmHg);
- Patients who take immunosuppressants, neoadjuvant chemotherapy and radiotherapy before surgery;
- Preoperative abnormal coagulation function.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated hospital of Nantong University
Nantong, Jiangsu, 226001
About this study
Official title: Effect of Lung Protective Ventilation Strategy on Tumor Inflammatory Microenvironment and Its Associated Hematological Composite Index in Patients Undergoing Colorectal Cancer Surgery
This study will be conducted in the Affiliated Hospital of Nantong University. Sixty colorectal cancer(CRC) patients are randomized into traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), there were 30 cases in each group. The control group adopted conventional ventilation strategy; the experimental group used lung protective ventilation strategy. 4ml of central venous blood was extracted at 3 time points within 24h, and relevant experimental indexes were determined. Observe the effect of lung protective ventilation strategy on the microenvironment of tumor inflammation and related hematological indexes in patients undergoing colorectal cancer surgery. Follow-up frailty score and quality of recovery score at 1,3,6, and 12 months after surgery (QoR-15 score scale).
Read the detailed description
This study will be conducted in the Affiliated Hospital of Nantong University. Sixty CRC patients are randomized into traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), there were 30 cases in each group. The control group adopted conventional ventilation strategies: tidal volume (VT)=10-12 ml/kg, respiratory rate ( f)=12 breaths / minute, positive end expiratory pressure（PEEP）=0 cmH₂O, fraction of inspired oxygen =0.5; the experimental group used lung protective ventilation strategies: tidal volume ( VT)=6-8 ml/kg, f=12 breaths / minute, positive end expiratory pressure (PEEP)=6-8 cmH₂O, fraction of inspired oxygen =0.5, mechanical ventilation every 30 minutes (continuous positive airway pressure 30 cmH₂O about 30 seconds). 4 ml of central venous blood was extracted at 3 time points within 24h, and relevant experimental indexes were determined. Observe the effect of lung protective ventilation strategy on the microenvironment of tumor inflammation and related hematological indexes NLDA, PDM, SII and PNI in patients undergoing colorectal cancer surgery. Follow-up frailty score and quality of recovery score at 1,3,6, and 12 months after surgery (QoR-15 score scale).
- Conditions
- Tumor Microenvironment
- Being tested
- Lung protective ventilation strategy
- Keywords
- Lung protective ventilation strategies, Tumor microenvironment, Colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung protective ventilation strategyProcedure or surgery
Also called conventional ventilation strategy
They were divided into 2 groups: traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), with 30 cases in each group. In the conventional ventilation strategy group, the conventional ventilation strategies were followed: tidal volume （VT）=10-12ml/kg, respiratory rate（f） =12 times/minute, PEEP=0 cmH₂O, fraction of inspired oxygen=0.5; Lung protective ventilation strategies were implemented in the Lung protective ventilation strategy group: VT=6-8ml/kg, f=12 times/min, PEEP=6-8 cm H₂O,fraction of inspired oxygen=0.5 Manual lung reexpansion was performed every 30 minutes after mechanical ventilation (continuous positive airway pressure of 30 cm H₂O for 30 seconds).
| Study group | Role | What they receive |
|---|---|---|
| conventional ventilation strategy group | Other | The conventional ventilation strategy group used a conventional ventilation strategies: tidal volume（VT）=10-12 ml/kg, respiratory rate（f）=12 beats/minute, end-expiratory positive pressure（PEEP）= 0 cm H₂O, fraction of inspired oxygen = 0.5 Receives: Procedure: Lung protective ventilation strategy |
| lung protective ventilation strategy group | Experimental | The lung protective ventilation strategy group used the lung protective ventilation strategies
: tidal volume（VT）=6-8 ml/kg, f=12 breaths / minute,end-expiratory positive pressure（PEEP） = 6-8 cmH₂O, and fraction of inspired oxygen = 0.5 . After mechanical ventilation every 30 minutes (continuous positive airway pressure 30 cmH₂O for 30 seconds). Receives: Procedure: Lung protective ventilation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microenvironment-related indicators of tumor inflammation
Concentrations of tumor necrosis factor alpha (TNF-α)
Measured: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation
Concentrations of nucleartranscriptionfactorkappaB (NF-kB)
Measured: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation
Concentrations of interleukin-6 (IL-6)
Measured: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation
Concentrations of Tumor-associated macrophages (TAMs)
Measured: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation
Concentrations of vascular endothelial growth factor (VEGF)
Measured: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation
Concentrations of Janus Kinase 1 (JAK1)
Measured: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation
Concentrations of signal transducer and activator of transcription 3 (STAT3)
Measured: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation
Concentrations of Protooncogene tyrosine protein kinase (C-Src)
Measured: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation
Concentrations of matrix metalloproteinases 2 (MMP-2)
Measured: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation
Concentrations of matrix metalloproteinases 9 (MMP-9)
Measured: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Secondary outcomes (4)
Comprehensive blood index
Values for NLDA (NLDA = neutrophil count/lymphocyte count × D-dimer count/albumin)
Measured: 10 minutes before anesthesia and 24 hours after the procedure
Comprehensive blood index
Values for PDM (PDM = platelet× D-dimer count)
Measured: 10 minutes before anesthesia and 24 hours after the procedure
Comprehensive blood index
Values for SII (SII= platelet× neutrophil / lymphocyte count)
Measured: 10 minutes before anesthesia and 24 hours after the procedure
Comprehensive blood index
Values for PNI (PNI = albumin + 5 × lymphocytes)
Measured: 10 minutes before anesthesia and 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start25 Jan 2024
- Primary completion1 Feb 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor MicroenvironmentStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongtao Gao, Affiliated Hospital of Nantong University
- Investigators
- Yongtao Gao, Master, Study director, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230965
- Sponsor's protocol ID
- LPVS-MS2023025
- Status last verified
- Sep 2025
- First submitted
- 9 Jan 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lung Protective Ventilation Strategy on Tumor Inflammatory Microenvironment and Its Associated Hematological Composite Index in Patients Undergoing Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT06230965
- Acronym / sponsor ID
- LPVS-MS2023025
- Conditions
- Tumor Microenvironment
- Keywords
- Lung protective ventilation strategies, Tumor microenvironment, Colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 Jan 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 study will be conducted in the Affiliated Hospital of Nantong University. Sixty colorectal cancer(CRC) patients are randomized into traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), there were 30 cases in each group. The control group adopted conventional ventilation strategy; the experimental group used lung protective ventilation strategy. 4ml of central venous blood was extracted at 3 time points within 24h, and relevant experimental indexes were determined. Observe the effect of lung protective ventilation strategy on the microenvironment of tumor inflammation and related hematological indexes in patients undergoing colorectal cancer surgery. Follow-up frailty score and quality of recovery score at 1,3,6, and 12 months after surgery (QoR-15 score scale).
Detailed description
This study will be conducted in the Affiliated Hospital of Nantong University. Sixty CRC patients are randomized into traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), there were 30 cases in each group. The control group adopted conventional ventilation strategies: tidal volume (VT)=10-12 ml/kg, respiratory rate ( f)=12 breaths / minute, positive end expiratory pressure（PEEP）=0 cmH₂O, fraction of inspired oxygen =0.5; the experimental group used lung protective ventilation strategies: tidal volume ( VT)=6-8 ml/kg, f=12 breaths / minute, positive end expiratory pressure (PEEP)=6-8 cmH₂O, fraction of inspired oxygen =0.5, mechanical ventilation every 30 minutes (continuous positive airway pressure 30 cmH₂O about 30 seconds). 4 ml of central venous blood was extracted at 3 time points within 24h, and relevant experimental indexes were determined. Observe the effect of lung protective ventilation strategy on the microenvironment of tumor inflammation and related hematological indexes NLDA, PDM, SII and PNI in patients undergoing colorectal cancer surgery. Follow-up frailty score and quality of recovery score at 1,3,6, and 12 months after surgery (QoR-15 score scale).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional ventilation strategy group | Other | Procedure: Lung protective ventilation strategyThe conventional ventilation strategy group used a conventional ventilation strategies: tidal volume（VT）=10-12 ml/kg, respiratory rate（f）=12 beats/minute, end-expiratory positive pressure（PEEP）= 0 cm H₂O, fraction of inspired oxygen = 0.5 |
| lung protective ventilation strategy group | Experimental | Procedure: Lung protective ventilation strategyThe lung protective ventilation strategy group used the lung protective ventilation strategies : tidal volume（VT）=6-8 ml/kg, f=12 breaths / minute,end-expiratory positive pressure（PEEP） = 6-8 cmH₂O, and fraction of inspired oxygen = 0.5 . After mechanical ventilation every 30 minutes (continuous positive airway pressure 30 cmH₂O for 30 seconds). |
Who may qualify
- Ages
- 51 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pathologic diagnosis of Colorectal Cancer
- American society of Aneshesiologists（ASA）physical status classification system Grade Ⅱ-Ⅲ;
- From 51-70 years old with no gender restrictions
- Normal cardiopulmonary function before operation
- Body Mass Index:18-30
Key exclusion criteria (6 listed)
- Preoperative anemia (hemoglobin<10g/dl)
- Patients with preoperative mechanical ventilation;
- A history of pulmonary infection and pulmonary tuberculosis within 1 month before surgery;
- Preoperative blood oxygen saturation (SpO₂) was less than 90% (SpO₂<90%), or the oxygen partial pressure (PaO₂) was less than 90% (PaO₂<60 mmHg), or PaO₂/fraction of inspired oxygen（FiO₂）ratio<300 mmHg, or arterial blood carbon dioxide partial pressure (PaCO₂) was greater than 45 mmHg (PaCO₂>45 mmHg);
- Patients who take immunosuppressants, neoadjuvant chemotherapy and radiotherapy before surgery;
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 |
|---|---|---|
| Lung protective ventilation strategyAlso: conventional ventilation strategyThey were divided into 2 groups: traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), with 30 cases in each group. In the conventional ventilation strategy group, the conventional ventilation strategies were followed: tidal volume （VT）=10-12ml/kg, respiratory rate（f） =12 times/minute, PEEP=0 cmH₂O, fraction of inspired oxygen=0.5; Lung protective ventilation strategies were implemented in the Lung protective ventilation strategy group: VT=6-8ml/kg, f=12 times/min, PEEP=6-8 cm H₂O,fraction of inspired oxygen=0.5 Manual lung reexpansion was performed every 30 minutes after mechanical ventilation (continuous positive airway pressure of 30 cm H₂O for 30 seconds). | Procedure or surgery | conventional ventilation strategy group, lung protective ventilation strategy group |
Primary outcome
Microenvironment-related indicators of tumor inflammation
Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Concentrations of tumor necrosis factor alpha (TNF-α)
Microenvironment-related indicators of tumor inflammation
Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Concentrations of nucleartranscriptionfactorkappaB (NF-kB)
Microenvironment-related indicators of tumor inflammation
Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Concentrations of interleukin-6 (IL-6)
Microenvironment-related indicators of tumor inflammation
Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Concentrations of Tumor-associated macrophages (TAMs)
Microenvironment-related indicators of tumor inflammation
Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Concentrations of vascular endothelial growth factor (VEGF)
Microenvironment-related indicators of tumor inflammation
Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Concentrations of Janus Kinase 1 (JAK1)
Microenvironment-related indicators of tumor inflammation
Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Concentrations of signal transducer and activator of transcription 3 (STAT3)
Microenvironment-related indicators of tumor inflammation
Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Concentrations of Protooncogene tyrosine protein kinase (C-Src)
Microenvironment-related indicators of tumor inflammation
Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Concentrations of matrix metalloproteinases 2 (MMP-2)
Microenvironment-related indicators of tumor inflammation
Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Concentrations of matrix metalloproteinases 9 (MMP-9)
4 secondary outcomes
Comprehensive blood index
Time frame: 10 minutes before anesthesia and 24 hours after the procedure
Comprehensive blood index
Time frame: 10 minutes before anesthesia and 24 hours after the procedure
Comprehensive blood index
Time frame: 10 minutes before anesthesia and 24 hours after the procedure
Comprehensive blood index
Time frame: 10 minutes before anesthesia and 24 hours after the procedure
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 25 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Yongtao Gao, Master study director
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung protective ventilation strategy in people with Tumor Microenvironment, run by Affiliated Hospital of Nantong 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 5 inclusion and 6 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 25 Mar 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?
Microenvironment-related indicators of tumor inflammation (time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure). The study lists 10 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 25 Mar 2026.