Akciğer Kanserinde (Lung Cancer) Sağkalım Sonuçları

Sade dilde özet

Bu çalışma, akciğer kanseri (lung cancer) olan hastalarda tedavi sonrası sağkalım sonuçlarını inceliyor. Katılım için 18 yaş ve üzeri, doku veya hücre incelemesiyle akciğer kanseri tanısı doğrulanmış ve ölçülebilir hastalığı olan hastalar uygundur. Faz uygulanmayan bir çalışma olarak yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Katılımcı alıyor

Sponsor

Hunan Province Tumor Hospital

Müdahale

Treatment

Başlangıç

01.08.2018

Tahmini bitiş

31.12.2030

Ülkeler

China

İlgili genler

Merkezler

• Changsha, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

1. Understand the requirements and contents of the clinical trial .
2. Age ≥ 18 years.
3. Histopathology or cytology confirmed lung cancer
4. ECOG \<=2.
5. Predicted survival ≥ 12 weeks.
6. Adequate bone marrow hematopoiesis and organ function
7. Presence of measurable lesions according to RECIST 1.1.

Exclusion Criteria:

1. Subjects who have received any of the following treatments must be excluded:

   * Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
   * Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
2. Presence of spinal cord compression or meningeal metastasis.
3. History of other malignant tumors within 2 years.
4. Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
5. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
6. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
7. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
8. Heart-related diseases or abnormalities
9. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
10. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb drugs due to previous bowel resection.
11. Live vaccine was given 2 weeks before the first medication.
12. Women who are breastfeeding or pregnant.
13. Hypersensitivity to the test drug and the ingredients.
14. Other conditions assessed by the investigator to be unsuitable for participation in the study.