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RecruitingNCT06547710ECTOP-1023Updated Jul 8, 2026

Primary Tumor Resection for M1a Stage Lung Cancer

An observational study in Lung Cancer Metastatic and Surgical Resection, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Fudan University · Observational

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
18 Years to 75 Years
Sex
All
01

Study 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 primary lesion resection can improve the OS and quality of life of the corresponding patients.

02

Conditions studied

  • Lung Cancer Metastatic
  • Surgical Resection
03

In context

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  1. Volunteer to participate in clinical research, willing to follow and able to complete all trial procedures;
  2. Aged 18-80 years (including critical values) when signing the informed consent form;
  3. ECOG score 0 or 1;
  4. No previous lung cancer surgery;
  5. Intraoperative or postoperative pathological confirmation of M1a stage lung cancer;
  6. Occult pleural metastasis found during surgery;
  7. First-time treatment and no radiotherapy or chemotherapy.

Exclusion criteria

Exclusion Criteria:

  1. The lesion cannot be completely removed surgically;
  2. Cytological or histological pathology confirms other lung malignancies other than lung cancer;
  3. Patients who have undergone lung cancer surgery before;
  4. Patients who have received radiotherapy or chemotherapy and are not treatment-naive patients.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Median overall survival

    Median overall survival for M1a patients underging surgery.

    Time frame: About 10months.

Secondary outcomes

  1. 2-year overall survival

    2-year overall survival

    Time frame: 2 years

  2. 5-year overall survival

    5-year overall survival

    Time frame: 5 years

  3. FEV1 and FVC

    Preoperative lung function test

    Time frame: 0.5 year

07

Study locations

1 of 1 sites recruiting
  • Fudan University Cancer Center
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06547710
Lead sponsor
Fudan University
Responsible party
Haiquan Chen (Director of Thoracic Surgery Department, Fudan University) — Principal investigator
First posted
Aug 9, 2024
Start date
Apr 1, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 8, 2026

Study contacts

Fangqiu Fu, MD
Contact
fufangqiu12@163.com
021-64175590

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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