Back to resultsEffect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium
Primary Purpose
Immunotherapy, Analgesia, NSCLC
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
neoadjuvant immunotherapy
Neoadjuvant chemotherapy
Sponsored by
About this trial
This is an interventional prevention trial for Immunotherapy
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed stage II or stage IIIA non-small cell lung cancer and meet the requirements for R0 resection;
- Has measurable disease assessed according to RECIST version 1.1;
- American Society of Anesthesiologists (ASA): I-II Class I-II, age ≥18 years, body mass index (BMI): 18.5-28 kg/m;
- Normal function of blood and vital organs such as heart, lungs and liver;
- Eligible to receive platinum-containing two-drug chemotherapy;
- Sign the informed consent form
Exclusion Criteria
- Prior treatment of any kind for current lung cancer, including chemotherapy or radiation therapy;
- Preoperative opioid analgesia;
- Locally advanced unresectable disease and metastatic disease;
- Any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to randomization;
- Active autoimmune disease or autoimmune disease that is likely to recur;
- History of interstitial lung disease, non-infectious pneumonia or poorly controlled disease (including pulmonary fibrosis, acute lung disease, etc.);
- Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection;
- History of antipsychotic medication in the last 6 months;
- Preoperative Mini-mental state examination (MMSE) score <23
Sites / Locations
- Tianjin Medical University Cancer Institute and HospitalRecruiting
- Tianjin Chest HospitalRecruiting
- Tianjin Medical University General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
neoadjuvant immunotherapy group
control group
Arm Description
Anti-PD-1 monoclonal antibody (Nivolumab，Pembrolizumab, Sintilimab, or Sugemalimab) 200 mg intravenously in combination with cis-platinum and paclitaxel/pemetrexed
platinum-containing dual-agent chemotherapy(cis-platinum and paclitaxel/pemetrexed)
Outcomes
Primary Outcome Measures
perioperative opioids usage
the amount of sufentanil, remifentanil and morphine application.
postoperative delirium
record the occurrence of postoperative delirium after surgery using the 3D-CAM test. Patient with postoperative delirium means worse outcome.
analgesic pump press in PICU
the time of first analgesic pump press in PICU
Secondary Outcome Measures
score of visual analog scale
Record the patient's resting and motor visual analog scale (VAS) scores, range from 0 to 10, and higher score means more pain.
dosage of sedatives
usage of propofol
level of cytokines
IL-6, IL-10, TNF-α
Full Information
NCT ID
NCT05273827
First Posted
October 7, 2021
Last Updated
August 23, 2022
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Tianjin Medical University General Hospital, Tianjin Chest Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05273827
Brief Title
Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium
Official Title
Clinical Observation of the Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium in Patients With Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Tianjin Medical University General Hospital, Tianjin Chest Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To observe the effect of preoperative anti-PD-1 monotherapy combined with chemotherapy on patients' perioperative pain and opioid analgesia, and evaluate its effect on the incidence and severity of patients' postoperative delirium.
Detailed Description
In this study, the investigators intend to select patients with resectable NSCLC treated with immuno-neoadjuvant therapy in combination with chemotherapy, systematically observe the effect of preoperative anti-PD-1 monotherapy on patients' perioperative pain and opioid analgesia, and evaluate its effect on the incidence and severity of patients' postoperative delirium, in order to provide a clinical basis for the perioperative management of patients treated with immuno-neoadjuvant therapy and promote their postoperative recovery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunotherapy, Analgesia, NSCLC, Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
In this study, the anesthesia management and documentation staff and the perioperative evaluation and follow-up staff were unaware of the grouping, and the study staff responsible for enrollment were informed of the patient grouping
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
neoadjuvant immunotherapy group
Arm Type
Experimental
Arm Description
Anti-PD-1 monoclonal antibody (Nivolumab，Pembrolizumab, Sintilimab, or Sugemalimab) 200 mg intravenously in combination with cis-platinum and paclitaxel/pemetrexed
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
platinum-containing dual-agent chemotherapy(cis-platinum and paclitaxel/pemetrexed)
Intervention Type
Drug
Intervention Name(s)
neoadjuvant immunotherapy
Other Intervention Name(s)
anti-PD-1 therapy
Intervention Description
Anti-PD-1 antibody was added to the conventional neoadjuvant chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant chemotherapy
Other Intervention Name(s)
Cis-platinum combined with paclitaxel or pemetrexed
Intervention Description
Cis-platinum combined with paclitaxel or pemetrexed
Primary Outcome Measure Information:
Title
perioperative opioids usage
Description
the amount of sufentanil, remifentanil and morphine application.
Time Frame
from beginning of surgery to day 3 after surgery
Title
postoperative delirium
Description
record the occurrence of postoperative delirium after surgery using the 3D-CAM test. Patient with postoperative delirium means worse outcome.
Time Frame
within 3 days after surgery
Title
analgesic pump press in PICU
Description
the time of first analgesic pump press in PICU
Time Frame
day 1 after surgery
Secondary Outcome Measure Information:
Title
score of visual analog scale
Description
Record the patient's resting and motor visual analog scale (VAS) scores, range from 0 to 10, and higher score means more pain.
Time Frame
at the time of admission to the operating room, immediately after and at 24 hour, 48 hour after entering the PICU
Title
dosage of sedatives
Description
usage of propofol
Time Frame
intraoperative
Title
level of cytokines
Description
IL-6, IL-10, TNF-α
Time Frame
up to 24 hour after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed stage II or stage IIIA non-small cell lung cancer and meet the requirements for R0 resection;
Has measurable disease assessed according to RECIST version 1.1;
American Society of Anesthesiologists (ASA): I-II Class I-II, age ≥18 years, body mass index (BMI): 18.5-28 kg/m;
Normal function of blood and vital organs such as heart, lungs and liver;
Eligible to receive platinum-containing two-drug chemotherapy;
Sign the informed consent form
Exclusion Criteria
Prior treatment of any kind for current lung cancer, including chemotherapy or radiation therapy;
Preoperative opioid analgesia;
Locally advanced unresectable disease and metastatic disease;
Any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to randomization;
Active autoimmune disease or autoimmune disease that is likely to recur;
History of interstitial lung disease, non-infectious pneumonia or poorly controlled disease (including pulmonary fibrosis, acute lung disease, etc.);
Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection;
History of antipsychotic medication in the last 6 months;
Preoperative Mini-mental state examination (MMSE) score <23
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaiyuan Wang, MD and Ph.D
Phone
13803036415
Email
93445729@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaiyuan Wang, MD
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaiyuan Wang, MD
Phone
+86 13803036415
Email
kywang@tmu.edu.cn
Facility Name
Tianjin Chest Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianxu Er, MD
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengcheng Song, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium
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