Lung Cancer MetastaticECTOP-1023NCT06547710
Primary Tumor Resection for M1a Stage Lung Cancer
An observational study of Lung Cancer Metastatic and Surgical Resection, run by Fudan University at 1 site in China.
Trial summary
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1023. This study aims to explore the safety and efficacy of primary lesion resection in the treatment of M1a stage lung cancer with pleural dissemination found during surgery, and to more accurately evaluate whether… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer Metastatic, Surgical Resection
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This clinical trial is a single-arm, multicenter, prospective, confirmatory phase II clinical study, which mainly evaluates the efficacy and safety of primary lesion resection for patients with M1a stage lung cancer who have occult pleural dissemination during surgery (Figure 1). Since it is unethical not to perform primary lesion resection during surgery for such patients, this study is a single-arm one. Primary lesion resection should be a resection that can completely remove the primary lesion, including lobectomy and sublobar resection.
Who may be able to join
- Volunteer to participate in clinical research, willing to follow and able to complete all trial procedures;
- Aged 18-80 years (including critical values) when signing the informed consent form;
- ECOG score 0 or 1;
- No previous lung cancer surgery;
- Intraoperative or postoperative pathological confirmation of M1a stage lung cancer;
- Occult pleural metastasis found during surgery;
- First-time treatment and no radiotherapy or chemotherapy.
Who cannot join
- The lesion cannot be completely removed surgically;
- Cytological or histological pathology confirms other lung malignancies other than lung cancer;
- Patients who have undergone lung cancer surgery before;
- Patients who have received radiotherapy or chemotherapy and are not treatment-naive patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Center
Shanghai, Shanghai Municipality, 200032
Chen Haiquan, MD, +86-21 64175590 ext. 1707, hqchen1@yahoo.com
About this study
Official title: Primary Tumor Resection for M1a Stage Lung Cancer With Occult Pleural Dissemination Discovered During Surgery: a Prospective, Single-arm, Multi-center, Phase Ⅱ Trial
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1023. This study aims to explore the safety and efficacy of primary lesion resection in the treatment of M1a stage lung cancer with pleural dissemination found during surgery, and to more accurately evaluate whether primary lesion resection can improve the OS and quality of life of the corresponding patients.
- Conditions
- Lung Cancer Metastatic, Surgical Resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Median overall survival
Median overall survival for M1a patients underging surgery.
Measured: About 10months.
Secondary outcomes (3)
2-year overall survival
2-year overall survival
Measured: 2 years
5-year overall survival
5-year overall survival
Measured: 5 years
FEV1 and FVC
Preoperative lung function test
Measured: 0.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547710
- Sponsor's protocol ID
- ECTOP-1023
- Acronym
- ECTOP-1023
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Tumor Resection for M1a Stage Lung Cancer With Occult Pleural Dissemination Discovered During Surgery: a Prospective, Single-arm, Multi-center, Phase Ⅱ Trial
- ClinicalTrials.gov ID
- NCT06547710
- Acronym / sponsor ID
- ECTOP-1023 / ECTOP-1023
- Conditions
- Lung Cancer Metastatic, Surgical Resection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Aug 2024 (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.
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1023. This study aims to explore the safety and efficacy of primary lesion resection in the treatment of M1a stage lung cancer with pleural dissemination found during surgery, and to more accurately evaluate whether primary lesion resection can improve the OS and quality of life of the corresponding patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical trial is a single-arm, multicenter, prospective, confirmatory phase II clinical study, which mainly evaluates the efficacy and safety of primary lesion resection for patients with M1a stage lung cancer who have occult pleural dissemination during surgery (Figure 1). Since it is unethical not to perform primary lesion resection during surgery for such patients, this study is a single-arm one. Primary lesion resection should be a resection that can completely remove the primary lesion, including lobectomy and sublobar resection.
Key inclusion criteria (7 listed)
- Volunteer to participate in clinical research, willing to follow and able to complete all trial procedures;
- Aged 18-80 years (including critical values) when signing the informed consent form;
- ECOG score 0 or 1;
- No previous lung cancer surgery;
- Intraoperative or postoperative pathological confirmation of M1a stage lung cancer;
Key exclusion criteria (4 listed)
- The lesion cannot be completely removed surgically;
- Cytological or histological pathology confirms other lung malignancies other than lung cancer;
- Patients who have undergone lung cancer surgery before;
- Patients who have received radiotherapy or chemotherapy and are not treatment-naive patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median overall survival
Time frame: About 10months.
Median overall survival for M1a patients underging surgery.
3 secondary outcomes
2-year overall survival
Time frame: 2 years
5-year overall survival
Time frame: 5 years
FEV1 and FVC
Time frame: 0.5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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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.
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 Metastatic and Surgical Resection, run by Fudan University 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fangqiu Fu, MD (021-64175590, fufangqiu12@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median overall survival (time frame: About 10months.). 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 8 Jul 2026.