Идёт набор NCT06413212
Exploratory Study of Precise Therapy for Advanced Tumor Patients With Malignant Hydrothorax or Ascites by Using PTC Drug Sensitivity Testing
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing..
- Кому может быть актуально
- Состояния в реестре: Lung Cancer, Breast Cancer, Gastric Cancer, Colorectal Cancer. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
To explore the consistency between result of PTC drug screening tests and actual clinical outcome for patients with advanced malignancy.
Подробное описание
This study is anticipated to enroll 55 patients with advanced malignancy, and fresh malignant effusion samples collected from patients would be detected by PTC drug screening. In addition, patients would receive 2 cycles of personal therapy based on results of screening tests. By combining PTC drug sensitivity results with patient's treatment process and clinical feedback, researchers may evaluate the sensitiveness and specificity of PTC drug screening technique in predicting clinical outcome for advanced malignancy patients.
Вмешательства
- Диагностический тест Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing.
Fresh malignant effusion samples were collected from advanced malignancy patients for PTC drug sensitivity testing, then assess the accuracy of this diagnostic test by combination and analysis with final clinical outcome.
Первичные конечные точки
- Complete Response (CR) [Срок оценки: up to 12 months]
- Partial Response (PR) [Срок оценки: up to 12 months]
- Progressive Disease (PD) [Срок оценки: up to 12 months]
- Stable Disease (SD) [Срок оценки: up to 12 months]
Критерии участия
Критерии включения
- 18 to 75 years old, regardless of gender.
- Score of nutrition risk screening 2002 (NRS2002) is less than 3, NRS20023.
- Advanced and unresectable malignancy confirmed by biopsy diagnosis.
- Able to tolerate anti-tumor treatment, and without serious cardiopulmonary and other underlying diseases.
- Score of eastern cooperative oncology group (ECOG) is not higher than 2, ECOG≤2.
- Anticipated survival exceed six months.
- At least one measurable lesions (according to RECIST 1.1)
- Resistance or intolerance to standard therapy regimens.
- Signed informed consent form voluntarily.
Критерии исключения
- Pregnant or lactating women.
- Have Participated other clinical trials in six months.
- Severe liver dysfunction.
- Severe renal dysfunction.
- Patients with cognitive disorder, mental diseases and terrible compliance.
- Allergic to known chemotherapeutic agents.
- Other circumstance not suitable to participate in this trial determined by investigators.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Китай · 1 центр
- Tongji Hospital — Ухань
Публикации
- Lim ZF, Ma PC. Emerging insights of tumor heterogeneity and drug resistance mechanisms in lung cancer targeted therapy. J Hematol Oncol. 2019 Dec 9;12(1):134. doi: 10.1186/s13045-019-0818-2. PMID 31815659
- Leonetti A, Sharma S, Minari R, Perego P, Giovannetti E, Tiseo M. Resistance mechanisms to osimertinib in EGFR-mutated non-small cell lung cancer. Br J Cancer. 2019 Oct;121(9):725-737. doi: 10.1038/s41416-019-0573-8. Epub 2019 Sep 30. PMID 31564718
- Passaro A, Janne PA, Mok T, Peters S. Overcoming therapy resistance in EGFR-mutant lung cancer. Nat Cancer. 2021 Apr;2(4):377-391. doi: 10.1038/s43018-021-00195-8. Epub 2021 Apr 15. PMID 35122001
- Doroshow DB, Sanmamed MF, Hastings K, Politi K, Rimm DL, Chen L, Melero I, Schalper KA, Herbst RS. Immunotherapy in Non-Small Cell Lung Cancer: Facts and Hopes. Clin Cancer Res. 2019 Aug 1;25(15):4592-4602. doi: 10.1158/1078-0432.CCR-18-1538. Epub 2019 Mar 1. PMID 30824587
- Wojas-Krawczyk K, Kalinka E, Grenda A, Krawczyk P, Milanowski J. Beyond PD-L1 Markers for Lung Cancer Immunotherapy. Int J Mol Sci. 2019 Apr 18;20(8):1915. doi: 10.3390/ijms20081915. PMID 31003463
- Reck M, Remon J, Hellmann MD. First-Line Immunotherapy for Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Feb 20;40(6):586-597. doi: 10.1200/JCO.21.01497. Epub 2022 Jan 5. PMID 34985920
- Blackley EF, Loi S. Targeting immune pathways in breast cancer: review of the prognostic utility of TILs in early stage triple negative breast cancer (TNBC). Breast. 2019 Nov;48 Suppl 1:S44-S48. doi: 10.1016/S0960-9776(19)31122-1. PMID 31839159
- Wang X, Wang SS, Huang H, Cai L, Zhao L, Peng RJ, Lin Y, Tang J, Zeng J, Zhang LH, Ke YL, Wang XM, Liu XM, Chen QJ, Zhang AQ, Xu F, Bi XW, Huang JJ, Li JB, Pang DM, Xue C, Shi YX, He ZY, Lin HX, An X, Xia W, Cao Y, Guo Y, Su YH, Hua X, Wang XY, Hong RX, Jiang KK, Song CG, Huang ZZ, Shi W, Zhong YY, Yuan ZY; South China Breast Cancer Group (SCBCG). Effect of Capecitabine Maintenance Therapy Using L PMID 33300950
Идентификаторы
NCT: NCT06413212 · TJ-IRB20230704