Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium

Sponsor

Tianjin Medical University Cancer Institute and Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05273827

Collaborator

Tianjin Medical University General Hospital (Other), Tianjin Chest Hospital (Other)

Enrollment

Locations

Arms

20.3

Anticipated Duration (Months)

23.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Immunotherapy Analgesia NSCLC Delirium	Drug: neoadjuvant immunotherapy Drug: Neoadjuvant chemotherapy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes 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

Primary Purpose:

Prevention

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

Actual Study Start Date :

Mar 22, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: neoadjuvant immunotherapy group Anti-PD-1 monoclonal antibody (Nivolumab，Pembrolizumab, Sintilimab, or Sugemalimab) 200 mg intravenously in combination with cis-platinum and paclitaxel/pemetrexed	Drug: neoadjuvant immunotherapy Anti-PD-1 antibody was added to the conventional neoadjuvant chemotherapy. Other Names: anti-PD-1 therapy
Placebo Comparator: control group platinum-containing dual-agent chemotherapy(cis-platinum and paclitaxel/pemetrexed)	Drug: Neoadjuvant chemotherapy Cis-platinum combined with paclitaxel or pemetrexed Other Names: Cis-platinum combined with paclitaxel or pemetrexed

Arm

Intervention/Treatment

Experimental: neoadjuvant immunotherapy group

Anti-PD-1 monoclonal antibody (Nivolumab，Pembrolizumab, Sintilimab, or Sugemalimab) 200 mg intravenously in combination with cis-platinum and paclitaxel/pemetrexed

Drug: neoadjuvant immunotherapy

Anti-PD-1 antibody was added to the conventional neoadjuvant chemotherapy.

Other Names:

anti-PD-1 therapy

Placebo Comparator: control group

platinum-containing dual-agent chemotherapy(cis-platinum and paclitaxel/pemetrexed)

Drug: Neoadjuvant chemotherapy

Cis-platinum combined with paclitaxel or pemetrexed

Other Names:

Cis-platinum combined with paclitaxel or pemetrexed

Outcome Measures

Primary Outcome Measures

perioperative opioids usage [from beginning of surgery to day 3 after surgery]
the amount of sufentanil, remifentanil and morphine application.
postoperative delirium [within 3 days after surgery]
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 [day 1 after surgery]
the time of first analgesic pump press in PICU

Secondary Outcome Measures

score of visual analog scale [at the time of admission to the operating room, immediately after and at 24 hour, 48 hour after entering the PICU]
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 [intraoperative]
usage of propofol
level of cytokines [up to 24 hour after surgery]
IL-6, IL-10, TNF-α

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin	China	300060
2	Tianjin Chest Hospital	Tianjin		China
3	Tianjin Medical University General Hospital	Tianjin		China

Sponsors and Collaborators

Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University General Hospital
Tianjin Chest Hospital

Investigators

Principal Investigator: Kaiyuan Wang, MD, Tianjin Medical University Cancer Institute and Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tianjin Medical University Cancer Institute and Hospital

ClinicalTrials.gov Identifier:

NCT05273827

Other Study ID Numbers:

bc2021131

First Posted:

Mar 10, 2022

Last Update Posted:

Aug 24, 2022

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Paclitaxel

Pemetrexed

Study Results

No Results Posted as of Aug 24, 2022