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Treatment of Gefitinib or Icotinib in lung adenocarcinoma of stage IA with micropapillary or solid

Treatment of Gefitinib or Icotinib in lung adenocarcinoma of stage IA with micropapillary or solid

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087186
Enrollment
Unknown
Registered
2024-07-22
Start date
2021-02-08
Completion date
Unknown
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung adenocarcinoma

Interventions

Control:None
Treatment:Patients to receive adjuvant therapy with gefitinib(250mg, once a day) or icotinib (125 mg, three times daily) for 24 months or to undergo observation until disease progression or intolerab

Sponsors

Weihai Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 78 Years

Inclusion criteria

Inclusion criteria: Patients with single primary lung cancer, a full set of tumor marker tests, blood biochemistry tests and related routine blood tests, enhanced CT of the chest, CT or ultrasound of the abdomen (liver, gallbladder, pancreas, spleen, kidneys, and adrenal glands), ultrasound of the cervical and supraclavicular lymph nodes, MR of the head or CT of the head, and whole-body bone imaging were all perfected to exclude metastasis before surgery; Complete surgical resection of the tumor with guaranteed negative margins (R0), the patient's surgical approach can be lobectomy, segmental resection, wedge resection of the lung, and regional lymph node sampling;Postoperative pathologically confirmed stage I lung adenocarcinoma (according to the 8th edition of the AJCC TNM staging system for lung cancer) with micropapillary or solid-type components;and had a confirmed EGFR mutation(exon 19 deletion or exon 21 L858R);Eligible patients were between 18 and 75 years of age; had an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.

Exclusion criteria

Exclusion criteria: Patients with multiple high-risk lung nodules; prior treatment with antitumor agents or radiotherapy.

Design outcomes

Primary

MeasureTime frame
disease-free survival;

Secondary

MeasureTime frame
overall survival;safety;

Countries

China

Contacts

Public ContactHuaijun Ji

Weihai Municipal Hospital

83113208@qq.com+86 185 6317 2120

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026