진행성 암 환자를 위한 자택 대 홈케어 항암 치료 대 클리닉 치료 비교 임상시험

At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer

안내

이 페이지는 자동 수집·AI 요약된 정보입니다. 의료 조언이 아니며, 치료 결정은 반드시 담당 의료진과 상의하세요. 응급 상황은 응급 가이드 또는 119.

항목	내용
등록번호	NCT05969860
상태	모집 중
단계	2상
시험 약물/중재	Clinical Encounter, Home Health Encounter, Quality-of-Life Assessment, Questionnaire Administration
대상 질환	Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma, Advanced Bladder Carcinoma, Advanced Breast Carcinoma, Advanced Carcinoid Tumor, Advanced Cervical Carcinoma
스폰서	Mayo Clinic
연령·성별	18 Years ~ 제한 없음 · ALL
목표 인원	220
시작 / 1차 완료 예정	2023-08-23 / 2027-01-01
국내 실시기관	없음
실시 국가	1개국, 기관 2곳 (United States)
결과 게시	아니오
최근 갱신	2026-04-20

문의처 (등록된 중앙 연락처)

• Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu

국내 기관 참여 문의는 해당 병원 임상시험센터 또는 담당 주치의를 통해 하세요. 참여 방법 안내

시험 개요

이 임상시험은 진행성 암(advanced cancer) 환자를 대상으로 병원 클리닉이 아닌 자택에서 표준 항암 치료를 받는 것의 효과와 안전성을 평가합니다. 환자들은 기존 클리닉 치료 또는 자택에서의 원격 모니터링 및 간호사 방문을 통한 치료(Cancer CARE Beyond Walls)에 무작위 배정됩니다. 주요 목표는 환자 보고 결과(patient-reported outcomes)와 삶의 질(quality of life)을 비교하는 것입니다. 목표 인원은 220명이며 현재 환자를 모집 중입니다.

• 목표 인원은 220명이며, 진행성 암 환자를 대상으로 합니다.
• 자택 치료군과 클리닉 치료군의 8주 차 환자 보고 자택 접근성 및 원격 전문성(CARE) 평점을 비교합니다.
• 24주 동안의 자택 주입에 대한 환자 선호도, 편안함, 삶의 질(EORTC QLQ-F17), 이상반응(PRO-CTCAE) 등을 평가합니다.
• 응급실 방문 및 입원율, 전체 생존기간(overall survival), 치료 비용 등을 부수적 또는 탐색적 목적으로 조사합니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 조직학적으로 확진된 악성 종양 환자 (간세포암은 영상 진단으로 대체 가능) - FDA 승인 또는 가이드라인에 따른 표준치료 요법(지정된 약물 및 요법)을 받고 있는 환자 - 동의 전 기존 표준 치료에 대한 내성이 적절하고 약물 관련 주입 반응이 없었던 환자 - 무작위 배정 후 주기 시작부터 최소 24주 동안 현재 처방된 치료 요법을 계속할 계획인 환자 - 공급업체 및 구급대원 네트워크의 서비스 지역 내 거주자 - 원격 지휘 센터와 안정적인 연결을 위한 무선 랜(wifi) 또는 무선 네트워크 솔루션 사용이 가능한 거주지 - 등록 시점 연령 18세 이상 - 서면 동의서 작성 완료 - 연구 프로토콜을 준수할 의지와 능력이 있는 자 - 미국동부암연구그룹(ECOG) 수행능력 상태(PS) 0, 1, 2

제외 기준: - 초록에 명시되지 않음

선정/제외 기준 원문 (영어)

Inclusion Criteria:

• Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis along; histologic confirmation is not required.

• Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines.

• Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Patients may receive any combination of any above listed medications or regimens:

• Eligible disease cancer types:

  • Anal cancer
  • Appendiceal carcinoma
  • Basal cell carcinoma
  • Bladder cancer
  • Biliary cancer
  • Breast cancer
  • Central Nervous System malignancy including glioblastoma
  • Cervical cancer
  • Cholangiocarcinoma
  • Colorectal carcinoma
  • Endometrial cancer
  • Fallopian tube cancer
  • Gastroesophageal cancer [including gastric, esophageal, and gastroesophageal junction (GEJ) cancers]
  • Germ cell carcinoma
  • Head and Neck cancer
  • Hepatocellular Carcinoma
  • Liver
  • Lung
  • Lymphoma
  • Melanoma
  • Merkel Cell
  • Multiple Myeloma
  • Myelodysplastic syndrome
  • Myeloid Disorders
  • Neuroendocrine carcinoma
  • Ovarian cancer
  • Pancreatic adenocarcinoma
  • Penile carcinoma
  • Peritoneal carcinoma
  • Prostate cancer
  • Renal cell cancer
  • Sarcoma
  • Squamous cell Carcinoma of the Skin
  • Testicular cancer
  • Urethral carcinoma
  • Vaginal carcinoma
  • Vulvar carcinoma

• Eligible Regimens

  • Fluorouracil (5-FU) +/- leucovorin +/- bevacizumab +/- trastuzumab
  • 5FU +/- leucovorin +/- bevacizumab +/- nivolumab
  • Atezolizumab +/- bevacizumab
  • Atezolizumab +/- bevacizumab + cobimetinib, atezolizumab +/- bevacizumab + vemurafenib, atezolizumab +/- bevacizumab + cobimetinib + vemurafenib
  • Avelumab
  • Avelumab + axitinib
  • Bevacizumab
  • Bevacizumab + capecitabine
  • Bevacizumab + irinotecan (+/- capecitabine)
  • Bevacizumab + olaparib, bevacizumab + lenvatinib, bevacizumab + niraparib, bevacizumab + rucaparib
  • Bevacizumab + Temozolomide, Bevacizumab + Lomustine, or Bevacizumab + everolimus
  • Bevacizumab + trifluridine/tipiracil
  • Bortezomib
  • Bortezomib + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor
  • Bortezomib + venetoclax
  • Carfilzomib
  • Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor
  • Carfilzomib + venetoclax
  • Cemiplimab
  • Cisplatin
  • Cisplatin/5-FU
  • Cisplatin/etoposide
  • Cisplatin + durvalumab
  • Cisplatin + gemcitabine
  • Cisplatin + gemcitabine + durvalumab
  • Daratumumab (+ oral [PO] cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
  • Daratumumab + bortezomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
  • Daratumumab + carfilzomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
  • Degarelix
  • Durvalumab
  • Durvalumab + tremelimumab
  • Eribulin
  • FOLFIRI +/- bevacizumab (5FU +/- leucovorin + irinotecan)
  • Fam-trastuzumab deruxtecan
  • Fulvestrant
  • Fulvestrant + ribociclib, fulvestrant + abemaciclib, fulvestrant + palbociclib, fulvestrant + alpelisib, or fulvestrant + capivasertib
  • Gemcitabine
  • Gemcitabine + durvalumab
  • Gemcitabine + paclitaxel protein-bound
  • Goserelin acetate
  • Irinotecan
  • Irinotecan + capecitabine
  • Lanreotide
  • Leuprolide
  • Nivolumab
  • Nivolumab + cabozantinib
  • Nivolumab-relatlimab
  • Octreotide
  • Paclitaxel
  • Pembrolizumab
  • Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +/- trametinib, pembrolizumab + trametinib)
  • Pemetrexed
  • Pertuzumab
  • Pemetrexed + pembrolizumab
  • Rituximab
  • Trastuzumab + paclitaxel
  • Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+/- tucatinib +/- capecitabine)
  • Decitabine

  • These regimens can be used only if patients are receiving one of the regimens above:

  • Darbepoetin-alfa

  • Epoetin
  • Filgrastim

• Note: Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the above eligible regimens may receive supportive care medications for treatment or prevention of bone metastases, including agents such as:

• Zoledronic acid

• Denosumab
• Patient has had adequate tolerability of their clinical standard of care cancer treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent
• Patients who according to documentation from their treating provider plan to continue the treatment regimen they are currently prescribed for at least 24 weeks from the start of cycle following randomization.
• Residing within the area serviced by supplier and paramedic network
• Residence has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center or it is suitable for connection through a wireless network solution
• Age >= 18 years at time of registration
• Signed informed consent form by patient
• Willing and able to comply with the study protocol in the investigator's judgement
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
• Ability to complete questionnaire(s) by themselves or with assistance
• RANDOMIZATION ELIGIBILITY CRITERIA: In addition to the criteria above, confirmation by the CCBW Command Center that the patient has adequate tolerability to the standard of care cancer therapy and no drug-related infusion reactions since pre-registration and prior to registration

Exclusion Criteria:

• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Note: Patients are permitted concomitant standard of care oral drugs such as ribociclib, abemaciclib, or palbociclib in combination with endocrine therapy (e.g., Leuprolide, fulvestrant intramuscular [IM], etc.); tucatinib and capecitabine in combination with trastuzumab and pertuzumab for HER2 positive breast cancer; dexamethasone, cyclophosphamide, lenalidomide or pomalidomide for multiple myeloma; temozolomide, lomustine, or afinitor in combination with avastin for glioblastoma. In addition, all oral anti-hormonal agents for breast and prostate cancer are permitted (e.g., tamoxifen, arimidex, abiraterone, etc.) if used in combination with any of the drugs
• Requiring 24/7 assistance with activities of daily living (ADLs)
• Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

• Uncontrolled intercurrent illness including, but not limited to:

• Ongoing or active infection

• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Myocardial infarction =\< 6 months
• Wound healing disorder
• Or psychiatric illness/social situations that would limit compliance with study requirements

출처: ClinicalTrials.gov · 수집 2026-10-06 · 갱신 2026-10-06

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