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

NCT05273827 | Completed

• 1 other identifier: bc2021131
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 3

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.

Conditions

Immunotherapy; Analgesia; NSCLC; Delirium

Outcome Measures

Primary Outcomes (1)

• perioperative opioids consumption

  the amount of sufentanil, remifentanil and morphine application.

  from beginning of surgery to day 3 after surgery

Secondary Outcomes (6)

• postoperative delirium

  within 3 days after surgery

• score of Numerical Rating Scale

  at the time of admission to the operating room, immediately after and at 24 hour, 48 hour, and 72h after entering the PICU

• analgesic pump press in PICU

  day 1, 2 and 3 after surgery

• Percent of patients with moderate to severe pain within 72 hours

  up to 72 hours after surgery

• intraoperative opioid consumption

  from the beginning to the end of the surgery

Other Outcomes (4)

• dosage of sedatives

  intraoperative

• level of cytokines

  before surgery and up to 24 hour after surgery

• Pathologic complete response (pCR) rate

  up to 30 days after surgery

Study Arms (2)

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

control group

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

Drug: Neoadjuvant chemotherapy

Interventions

neoadjuvant immunotherapy DRUG

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

Also known as: anti-PD-1 therapy

neoadjuvant immunotherapy group

Neoadjuvant chemotherapy DRUG

Cis-platinum combined with paclitaxel or pemetrexed

Also known as: Cis-platinum combined with paclitaxel or pemetrexed

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with NSCLC receiving neo-adjuvant chemotherapy or chemotherapy combined with immunotherapy followed by radical surgery will be screened and recruited in this study.

You may qualify if:

• Histologically confirmed stage II or stage IIIA non-small cell lung cancer (NSCLC) and meet the requirements for R0 resection;
• American Society of Anesthesiologists (ASA): I-III, age ≥18 years, body mass index (BMI): 18.5-30;
• Normal function of Coagulation and vital organs such as heart, lungs, kidney, and liver;
• Eligible to receive platinum-containing two-drug chemotherapy;
• Sign the informed consent form

You may not qualify if:

• Prior treatment of any kind for current lung cancer, including chemotherapy, radiation or targeted therapy;
• Preoperative opioid analgesia;
• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Tianjin Medical University General Hospital: collaborator
• Tianjin Chest Hospital: collaborator

Study Sites (3)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Tianjin Chest Hospital

Tianjin, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

Related Publications (1)

• Wang K, Er J, Zhang Y, Song C, Yu Y, Gao R, Xu H, Dong X, Yuan L, Liu Q, Han J, Yu Y, Yin Y. Increased opioid consumption in neoadjuvant immunotherapy plus chemotherapy for patients with non-small-cell lung cancer: A multicenter, prospective cohort study. CNS Neurosci Ther. 2024 Aug;30(8):e14893. doi: 10.1111/cns.14893.

  PMID: 39097916 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be obtained perioperatively. The serum will be further separated and frozen at -80 degrees.

MeSH Terms

Conditions

Agnosia; Delirium

Interventions

Neoadjuvant Therapy; Paclitaxel; Pemetrexed

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Confusion; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Kaiyuan Wang, MD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: March 10, 2022
• Study Start: March 22, 2022
• Primary Completion: December 20, 2023
• Study Completion: January 2, 2024
• Last Updated: January 5, 2024

Record last verified: 2023-11

Locations

CN (3)