ImmunotherapyNCT05273827
Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium
An observational study of Immunotherapy and Analgesia, run by Tianjin Medical University Cancer Institute and Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunotherapy, Analgesia, NSCLC
- What is being tested?
- neoadjuvant immunotherapy and Neoadjuvant chemotherapy
- Type of treatment
- Injection or infusion
- How many people
- 81 participants
- Where
- 3 sitesChina
- Study dates
- 22 Mar 2022to 2 Jan 2024
- 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: Patients with NSCLC receiving neo-adjuvant chemotherapy or chemotherapy combined with immunotherapy followed by radical surgery will be screened and recruited in this study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Tianjin Chest Hospital
Tianjin
Tianjin Medical University General Hospital
Tianjin
About this study
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
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.
Read the 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.
- Conditions
- Immunotherapy, Analgesia, NSCLC, Delirium
- Being tested
- neoadjuvant immunotherapy, Neoadjuvant chemotherapy
- Medical subject headings
- Agnosia, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant immunotherapyDrug
Also called anti-PD-1 therapy
Anti-PD-1 antibody was added to the conventional neoadjuvant chemotherapy.
Neoadjuvant chemotherapyDrug
Also called Cis-platinum combined with paclitaxel or pemetrexed
Cis-platinum combined with paclitaxel or pemetrexed
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant immunotherapy group | Anti-PD-1 monoclonal antibody (Nivolumab，Pembrolizumab, Sintilimab, or Sugemalimab) 200 mg intravenously in combination with cis-platinum and paclitaxel/pemetrexed Receives: Drug: neoadjuvant immunotherapy | |
| control group | platinum-containing dual-agent chemotherapy(cis-platinum and paclitaxel/pemetrexed) Receives: Drug: Neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative opioids consumption
the amount of sufentanil, remifentanil and morphine application.
Measured: from beginning of surgery to day 3 after surgery
Secondary outcomes (6)
postoperative delirium
record the occurrence of postoperative delirium after surgery using the 3D-CAM test. Patient with postoperative delirium means worse outcome.
Measured: within 3 days after surgery
score of Numerical Rating Scale
Record the patient's resting and motor Numerical Rating Scale (NRS) scores, range from 0 to 10, and higher score means more pain.
Measured: 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
the time of first analgesic pump press and no. of total press in PICU
Measured: day 1, 2 and 3 after surgery
Percent of patients with moderate to severe pain within 72 hours
Moderate to severe pain is defined as any NRS pain score of 4 or higher.
Measured: up to 72 hours after surgery
intraoperative opioid consumption
the amount of sufentanil and remifentanil
Measured: from the beginning to the end of the surgery
postoperative opioid consumption
opioid usage in PCIA and supplemental analgesics within 72 h
Measured: up to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start22 Mar 2022
- Primary completion20 Dec 2023
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Tianjin Chest Hospital
- Responsible party
- Sponsor
- Investigators
- Kaiyuan Wang, MD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273827
- Sponsor's protocol ID
- bc2021131
- Status last verified
- Nov 2023
- First submitted
- 7 Oct 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39097916
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05273827
- Acronym / sponsor ID
- bc2021131
- Conditions
- Immunotherapy, Analgesia, NSCLC, Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Tianjin Chest Hospital
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 10 Mar 2022 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant immunotherapy group | – | Drug: neoadjuvant immunotherapyAnti-PD-1 monoclonal antibody (Nivolumab，Pembrolizumab, Sintilimab, or Sugemalimab) 200 mg intravenously in combination with cis-platinum and paclitaxel/pemetrexed |
| control group | – | Drug: Neoadjuvant chemotherapyplatinum-containing dual-agent chemotherapy(cis-platinum and paclitaxel/pemetrexed) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| neoadjuvant immunotherapyAlso: anti-PD-1 therapyAnti-PD-1 antibody was added to the conventional neoadjuvant chemotherapy. | Drug | neoadjuvant immunotherapy group |
| Neoadjuvant chemotherapyAlso: Cis-platinum combined with paclitaxel or pemetrexedCis-platinum combined with paclitaxel or pemetrexed | Drug | control group |
Primary outcome
perioperative opioids consumption
Time frame: from beginning of surgery to day 3 after surgery
the amount of sufentanil, remifentanil and morphine application.
6 secondary outcomes
postoperative delirium
Time frame: within 3 days after surgery
score of Numerical Rating Scale
Time frame: 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
Time frame: day 1, 2 and 3 after surgery
Percent of patients with moderate to severe pain within 72 hours
Time frame: up to 72 hours after surgery
intraoperative opioid consumption
Time frame: from the beginning to the end of the surgery
postoperative opioid consumption
Time frame: up to 72 hours after surgery
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 5 Jan 2024.
- Derived from this study: PubMed 39097916Wang 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.
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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.
Kaiyuan Wang, MD principal investigator
Tianjin Medical University Cancer Institute and Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunotherapy and Analgesia, run by Tianjin Medical University Cancer Institute and Hospital at 3 sites 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 5 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
perioperative opioids consumption (time frame: from beginning of surgery to day 3 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05273827, which also lists 1 linked publication.
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 5 Jan 2024.