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A prospective observational study of hepatitis B virus (HBV) reactivation during targeted therapy with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-Tkis) in patients with chronic hepatitis B virus (HBV) -infected non-small cell lung cancer

A single-center, prospective, observational study of hepatitis B virus reactivation during targeted therapy with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-Tkis) in patients with chronic hepatitis B virus (HBV) -infected non-small cell lung cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062913
Enrollment
Unknown
Registered
2022-08-23
Start date
2022-08-23
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

non-small cell lung cancer

Interventions

one:EGFR-TKIs targeted therapy was accepted

Sponsors

Meizhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this study: 1. Older than or equal to 18 years of age, younger than or equal to 75 years of age, male or female; 2. Non-small cell lung cancer was pathologically confirmed with EGFR gene sensitive mutation, and EGFR-TKIS targeted therapy was planned; 3. Chronic HBV infection: HBsAg and/or HBV-DNA positive, ALT normal; 4. If there is no prior palliative chemotherapy or immunotherapy, prior adjuvant chemotherapy or immunotherapy is allowed to be enrolled, but the end of adjuvant chemotherapy or adjuvant immunotherapy is required to be more than 6 months from the beginning of the study observation, and the end of adjuvant immunotherapy is required to be more than 12 months from the beginning of the study observation; 5. Life expectancy >=3 months; 6. Understand and voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: Patients with any of the following conditions cannot be enrolled in this study: 1. A history of acute or severe hepatitis; 2. Previous anti-hepatitis B treatment; 3. Complicated with other types of hepatitis virus infection (hepatitis A, c, etc.); 4, combined with immune diseases or long-term oral immunosuppressants; 5. Any other obvious clinical manifestations or laboratory abnormalities preclude the patient from participating in the clinical study; 6. decompensated fatty liver, alcoholic liver, cirrhosis, biliary diseases, etc.; 7. Using other drugs that may cause hbV-DNA reactivation, such as hormones; 8. Pregnancy or breastfeeding.

Design outcomes

Primary

MeasureTime frame
HBV-DNA;therapy and response criteria evaluation;

Countries

China

Contacts

Public ContactGuowu Wu
wwwflay@126.com13823801920

Outcome results

None listed

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