NCT07106528Toborzás még nem indult2/3. fázis
Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer
Organoid-Based Drug Sensitivity Model Guided Personalized Precision Treatment for Extensive-Stage Small Cell Lung Cancer: A Prospective, Multicenter, Randomized Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. aug. 6. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
This study aims to provide personalized treatment options for patients with extensive-stage small cell lung cancer (SCLC) whose disease has worsened after initial chemotherapy. Researchers will use a novel approach called "tumor organoid drug sensitivity testing": A small sample of the patient's tumor (from biopsy or fluid) is grown into miniature 3D tumor models ("organoids") in the lab. These organoids are exposed to various FDA-approved second-line drugs (including chemotherapy and newer targeted/immunotherapy drugs if available). The most effective drug for each patient's organoids will be recommended for their treatment. 128 participants will be randomly assigned to one of two groups:Experimental Group: Receive organoid-guided personalized therapy; Control Group: Receive standard second-line chemotherapy (Topotecan). The study will compare: How long the cancer remains controlled (Progression-Free Survival); Overall survival time; Treatment response rates and side effects. Potential benefits: May identify more effective treatments for individual patients; Could extend time without cancer progression. Risks: Organoid testing requires an additional tumor biopsy/fluid collection; Possible side effects from second-line drugs.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2/3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 128 (tervezett)
- Első benyújtás
- 2025. júl. 22.
- Kezdés
- 2025. aug.
- Elsődleges befejezés
- 2027. dec.
- Fő szponzor
- Peking Union Medical College Hospital
- Betegségek
- Tüdőrák
- NCT-szám
- NCT07106528
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2/3. fázis
- Tervezett résztvevők: 128
- 2025. aug. és az elsődleges befejezés (2027. dec.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Previous receipt of second-line or higher systemic anti-tumor therapy for ES-SCLC.
Más betegség
- History of other malignant tumors that are progressive or require active treatment within the past 5 years.
- Presence of active infections, severe organ dysfunction, or other contraindications to anti-tumor treatment.
- Inability to obtain tumor tissue or insufficient malignant serous effusion for collection.
Egyéb
- Mixed tumor pathology or lack of histological confirmation.
- Symptomatic or progressive brain metastases, or meningeal metastases.
- Expected survival of less than 3 months.
- Inability to complete standardized clinical diagnosis/treatment or regular follow-up.
Kiket keres a vizsgálat
- Aged 18 years or older.
- Pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (AJCC 9th edition, Stage IV).
- Previously received first-line platinum-based systemic chemotherapy and experienced recurrence or progression during first-line treatment or within ≤ 6 months after completion of first-line treatment.
- Availability of sufficient tumor tissue or malignant serous effusion for organoid culture.
- Presence of measurable lesions based on RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate bone marrow and organ function, confirmed by baseline blood count, blood biochemistry, and urine biochemistry tests.
- Asymptomatic and stable central nervous system (CNS) metastases are allowed.
- Expected survival of at least 3 months.
- For male participants: Agreement to use effective contraception during treatment and for at least 180 days after the last dose of study treatment; prohibition of sperm donation during this period.
- For female participants: Not pregnant or breastfeeding, and meeting at least one of the following:
- Women of non-childbearing potential; or Agreement to use effective contraception during treatment and for at least 180 days after the last dose of study treatment; or Women of childbearing potential must have a negative serum or urine pregnancy test (with a minimum sensitivity of 25 IU/L or HCG equivalent units) within 72 hours before initiating treatment.
- Voluntary participation with signed informed consent and willingness to comply with study follow-up procedures.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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