Lung CancerNCT06023797
Neoadjuvant Immunochemotherapy for Lung Cancer
An observational study of Lung Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
We retrospectively analyzed lung cancer patients who had NAICT and surgery in the Department of Thoracic Surgery, Zhongshan Hospital. NAICT was defined as chemotherapy that included at one application of PD-1 inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Neoadjuvant immunochemotherapy
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Jul 2023
- 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 who received NAICT and were operated at the Department of Thoracic Surgery, Zhongshan Hospital Fudan University between 2017 and 2022.
Who may be able to join
- Lung surgery was performed in the Department of Thoracic Surgery at Zhongshan Hospital;
- At least one cycle of neoadjuvant treatment containing the immune drug PD-1 immunosuppressant was performed before surgery;
- Malignancy was present and confirmed in the pathology before treatment and after surgery;
- The lung lesion was the primary lesion.
Who cannot join
- No lung surgery was performed until 2022.11;
- No preoperative neoadjuvant therapy was performed or recorded;
- Neoadjuvant therapy did not include immune drugs;
- Previous history of malignancy (including surgery and adjuvant therapy);
- Previous use of system-related immune medicines, such as immunosuppressants and monoclonal antibodies; and 6. Other conditions inappropriate for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Research on Lung Cancer Patients Receiving Neoadjuvant Immunochemotherapy From Zhongshan Hospital Fudan University.
We retrospectively analyzed lung cancer patients who had NAICT and surgery in the Department of Thoracic Surgery, Zhongshan Hospital. NAICT was defined as chemotherapy that included at one application of PD-1 inhibitor.
- Conditions
- Lung Cancer
- Being tested
- Neoadjuvant immunochemotherapy
- Keywords
- neoadjuvant therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant immunochemotherapyDrug
Also called surgery
Patients who received NAICT and were operated at the Department of Thoracic Surgery, Zhongshan Hospital Fudan University between 2017 and 2022.
| Study group | Role | What they receive |
|---|---|---|
| MAICT | chemotherapy that included at one application of PD-1 inhibitor Receives: Drug: Neoadjuvant immunochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free defined as status of recurrence of lung cancer
Measured: 2017-2023
Overall survival (OS)
Overall defined as the living status, alive or dead
Measured: 2017-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study startJan 2017
- Primary completionNov 2022
- Study completionJul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023797
- Sponsor's protocol ID
- ZS-chest
- Status last verified
- Sep 2023
- First submitted
- 28 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Research on Lung Cancer Patients Receiving Neoadjuvant Immunochemotherapy From Zhongshan Hospital Fudan University.
- ClinicalTrials.gov ID
- NCT06023797
- Acronym / sponsor ID
- ZS-chest
- Conditions
- Lung Cancer
- Keywords
- neoadjuvant therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Nov 2022 (actual)
- Study completion
- Jul 2023 (actual)
- First posted
- 5 Sep 2023 (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.
We retrospectively analyzed lung cancer patients who had NAICT and surgery in the Department of Thoracic Surgery, Zhongshan Hospital. NAICT was defined as chemotherapy that included at one application of PD-1 inhibitor.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAICT | – | Drug: Neoadjuvant immunochemotherapychemotherapy that included at one application of PD-1 inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who received NAICT and were operated at the Department of Thoracic Surgery, Zhongshan Hospital Fudan University between 2017 and 2022.
Key inclusion criteria (4 listed)
- Lung surgery was performed in the Department of Thoracic Surgery at Zhongshan Hospital;
- At least one cycle of neoadjuvant treatment containing the immune drug PD-1 immunosuppressant was performed before surgery;
- Malignancy was present and confirmed in the pathology before treatment and after surgery;
- The lung lesion was the primary lesion.
Key exclusion criteria (5 listed)
- No lung surgery was performed until 2022.11;
- No preoperative neoadjuvant therapy was performed or recorded;
- Neoadjuvant therapy did not include immune drugs;
- Previous history of malignancy (including surgery and adjuvant therapy);
- Previous use of system-related immune medicines, such as immunosuppressants and monoclonal antibodies; and 6. Other conditions inappropriate for enrollment by the investigator.
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 immunochemotherapyAlso: surgeryPatients who received NAICT and were operated at the Department of Thoracic Surgery, Zhongshan Hospital Fudan University between 2017 and 2022. | Drug | MAICT |
Primary outcome
Progression-free survival (PFS)
Time frame: 2017-2023
Progression-free defined as status of recurrence of lung cancer
Overall survival (OS)
Time frame: 2017-2023
Overall defined as the living status, alive or dead
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 Sep 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Shanghai Zhongshan Hospital 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 4 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 Sep 2023. 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?
Progression-free survival (PFS) (time frame: 2017-2023). The study lists 2 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 5 Sep 2023.