TAPISTRY是一項第二期、全球性、多中心、開放標籤、多隊列研究,旨在評估標靶治療或免疫治療作為單藥或合理指定聯合方案,用於經確效次世代基因定序(NGS)識別出帶有特定致癌基因組改變或被確定為腫瘤突變負荷(TMB)高的不可切除、局部晚期或轉移性實體瘤參與者的安全性及療效。
適應症:Solid Tumors
收案條件
納入條件
- Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
- Measurable disease as defined by RECIST v1.1, RANO, or INRC
- Performance status as follows: Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participants aged 16 to \< 18 years: Karnofsky score ≥ 50%; Participants aged \< 16 years: Lansky score ≥ 50%
- For participants aged ≥ 18 and \< 18 years: adequate hematologic and end-organ function
- Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
- Adequate recovery from most recent systemic or local treatment for cancer
- Life expectancy ≥ 8 weeks
- Ability to comply with the study protocol, in the investigator's judgment
排除條件
- Current participation or enrollment in another therapeutic clinical trial
- Any anticancer treatment within 2 weeks or 5 half-lives prior to start of study treatment
- Whole brain radiotherapy within 14 days prior to start of study treatment
- Stereotactic radiosurgery within 7 days prior to start of study treatment
- Pregnant or breastfeeding, or intending to become pregnant during the study
- History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study or confounds the ability to interpret data from the study
- Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
- History of another active cancer within 5 years prior to screening that may interfere with the determination of safety or efficacy of study treatment with respect to the qualifying solid tumor malignancy
收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。