Skip to content

The analysis the efficacy of EGFR-TKIs to the patients with EGFR sensitive mutations with or without bone metastases

The analysis the efficacy of EGFR-TKIs to the patients with EGFR sensitive mutations with or without bone metastases

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000030455
Enrollment
Unknown
Registered
2020-03-02
Start date
2020-03-01
Completion date
Unknown
Last updated
2020-03-09

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

Conditions

lung cancer

Interventions

Case series:Nil

Sponsors

Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. Cytologically or histologically proven diagnosis of adenocarcinoma; 3. Stage IV according to AJCC (8th edition of 2016); 4. ECOG performance status 0-3; 5. No prior chemotherapy and immunotherapy (postoperative adjuvant therapy must be completed>=6 months); 6. Radiotherapy must be completed>=4 weeks and the acute toxicities must been restored; previous radiotherapy lesion cannot be target tumor lesion unless progress; 7. EGFR sensitive mutations(exon 19 delection or exon 21 L858R); 8. received erlotinib 150mg daily 1 hour before dinner or 2 hours after dinner as the first line therapy; 9. at least one target tumor lesion can be measured by CT or MRI(the long diameter of tumor lesion >=10mm, the short diameter of lymph node lesions >=15mm and the target lesions not be treated with radiotherapy or freezing and so on); 10. Life expectancy of at least 3 months; 11. The major organs function are normal: ANC>=1.5x10^9/L, PLT>=100x10^9/L, Hb>=100g/L, TBIL <1.5 ULN, ALT and AST <2.5 ULN, BUN and Cr<=1 ULN; 12. Follow research requirements and follow-up surveillance, signed informed consent form; 13. Clinical data integrity.

Exclusion criteria

Exclusion criteria: (1) Serious violation of the inclusion criteria; (2) Can not follow the research requirements and follow-up surveillance; (3) Mentally disabled; (4) The change or death occurring during follow-up and no related to the experimental factors.

Design outcomes

Primary

MeasureTime frame
objective response rate;progression free survival;

Countries

China

Contacts

Public ContactKan Jiang

Fujian Cancer Hospital

jasmine9576@sina.com+86 13600886062

Outcome results

None listed

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