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전이성 췌장암 환자에서 종양치료전기장(TTFields)과 화학요법 병용 임상시험

TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)

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 NCT07284277
상태 모집 중
단계 1상/2상
시험 약물/중재 TTFields concomitant with modFOLFIRINOX
대상 질환 Pancreatic Adenocarcinoma Metastatic, Pancreatic Ductal Adenocarcinoma
스폰서 Clinica Universidad de Navarra, Universidad de Navarra
연령·성별 18 Years ~ 제한 없음 · ALL
목표 인원 30
시작 / 1차 완료 예정 2025-10-14 / 2027-03
국내 실시기관 없음
실시 국가 1개국, 기관 5곳 (Spain)
결과 게시 아니오
최근 갱신 2025-12-16

문의처 (등록된 중앙 연락처)

  • Mariano Ponz Sarvisé, MD, PhD +34 948255400 mponz@unav.es
  • Lucía Ceniceros +34 948255400 lceniceros@unav.es

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

시험 개요

이 임상시험은 전이성 췌장암(Metastatic Pancreatic Adenocarcinoma) 성인 환자를 대상으로 종양치료전기장(TTFields)과 변형 FOLFIRINOX(modFOLFIRINOX) 화학요법 병용 치료의 안전성과 내인성을 평가합니다. 연구는 NovoTTF-200T 시스템과 modFOLFIRINOX의 병용 안전성을 확인하기 위한 제1b상 및 제2상, 비무작위 배정, 공개, 단일군, 다기관 연구로 진행됩니다. 총 목표 인원은 30명이며 환자들은 최대 24개월 동안 참여하게 됩니다. 초록에 유효성 결과 수치는 명시되지 않았습니다.

  • 목표 인원은 30명의 전이성 췌장암 환자입니다.
  • 중재 치료는 NovoTTF-200T 시스템을 이용한 종양치료전기장(TTFields)과 modFOLFIRINOX 화학요법의 병용입니다.
  • 제1b상 안전성 평가 코호트(6명)와 제2상 확장 코호트로 나누어 진행됩니다.
  • 초록에 생존기간, 반응률, 위험비 등의 유효성 수치는 명시되지 않았습니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 조직학적 또는 세포학적으로 진단된 췌장암 환자 - 만 18세 이상 - 연구 참여에 동의하고 요구사항을 준수할 수 있는 환자 - 예상 여명 3개월 이상 - 생검 가능한 간 전이 병변이 최소 1개 이상 있는 전이성 질환 - 고형암 반응평가기준(RECIST 1.1)에 따른 측정 가능한 병변 보유 - 미국동부종양학협회(ECOG) 신체 상태 평점 0 또는 1 - modFOLFIRINOX 치료가 가능하고 연구자가 배정함 - 환자 스스로 또는 보호자의 도움으로 Novo TTF-200T 시스템을 조작할 수 있는 자 - 적절한 혈액학 및 장기 기능 보유 제외 기준: - 첫 치료 주기 1일차 기준 3년 이내에 췌장암 외의 다른 악성 종양 병력이 있는 환자 (완치율이 높은 특정 암 제외) - 전이성 췌장관암에 대해 이전에 화학요법을 받은 경우 - 치료되지 않은 중추신경계(CNS) 전이 - 5-FU 독성을 유발할 수 있는 디히드로피리미딘 탈수소효소 결핍증 또는 티미딜산 합성효소 유전자 다형성 - 몸통에 심박동기 등 이식형 전자 의료기기가 있는 환자 - 의료용 접착제나 하이드로겔에 대한 심각한 과민반응 병력 - 임산부 및 수유부 - 조절되지 않는 심혈관 질환 등 심각한 동반 질환

선정/제외 기준 원문 (영어)

Inclusion Criteria:

All the patients should comply with the following criteria for inclusion:

  1. Histological/cytological diagnosis of pancreatic adenocarcinoma.
  2. The patient should be 18 years of age and older.
  3. The patient has given consent to participate in the study.
  4. The patient should be able to comply with all the requirements of the clinical trial.
  5. Life expectancy of at least 3 months.
  6. Metastatic disease with, at least, one hepatic lesion that must be accessible for biopsy.
  7. Measurable disease as defined by Response Evaluation Criteria in Solid Tumor v1.1 (RECIST 1.1) apart from the liver lesion to be biopsied.
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  9. Amenable and assigned by the investigator to receive therapy with modFOLFIRINOX.
  10. Prior chemotherapy or radiotherapy on the neoadjuvant or adjuvant setting is allowed as long as at least six months have elapsed since last chemotherapy treatment.
  11. Able to operate the Novo TTF-200T System independently or with the help of a caregiver.

  12. Adequate hematologic and organ function, defined by the following laboratory test results, obtained during the screening period and before C1D1.

    1. WBC higher than or equal to 2.5 x 10\^9/L.
    2. ANC higher than or equal to 1.5 x 10\^9/L without granulocyte colony-stimulating factor support.
    3. Platelet count higher than or equal to 100 x 10\^9/L without transfusion.
    4. Hemoglobin higher than or equal to 9 g/dL. Patients may be transfused to meet this criterion.
    5. Albumin higher than or equal to 2.5 g/dL.
    6. Serum bilirubin lower than or equal to 1.5 times the upper limit of normal (ULN); patients with known Gilbert´s disease may have a bilirubin value lower than or equal to 3 x ULN.
    7. INR and aPTT lower than or equal to 1.5 x ULN.
    8. AST, ALT, lower than or equal to 5 x ULN.
    9. Serum creatinine lower than or equal to 1.5 x ULN or Creatinine Clearance higher than or equal to 30ml/min (calculated using Cockcroft-Gault formula).

  13. For women of childbearing potential: Negative serum pregnancy test within 14 days prior to C1D1. Agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraceptive methods that result in a failure rate of lower than or equal to 1 percentage per year during the treatment period (combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal o transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable o implantable); intrauterine device (IUD) or intrauterine hormone-releasing system (IUS); bilateral tubal occlusion or vasectomized partner) and for at least 180 days after the last study treatment. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (higher than or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).

Exclusion Criteria:

Patients who present any of the following criteria for exclusion cannot be included in the clinical trial:

  1. Malignancies other than pancreatic cancer within 3 years prior to Cycle 1 Day 1 (C1D1) with the exceptions of those with a negligible risk of metastasis or death (e.g., expected 5-year overall survival higher than 90 percentage), treated with expected curative outcome (such as but not limited to: adequately treated in situ carcinoma of the cervix, basal squamous or melanomatous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ of the breast treated surgically with curative intent).
  2. Previous treatment with chemotherapy for metastatic pancreatic ductal adenocarcinoma.
  3. Untreated CNS metastases. Treatment of brain metastases, either by surgical or radiation techniques, must have been completed at least 4 weeks prior to study entry.
  4. Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5-fluorouracil (5-FU) toxicity.
  5. Previous radiation therapy within 14 days prior to C1D1 and/or persistence of radiation-related adverse effects.
  6. Implantable electronic medical devices in the torso, such as pacemakers.
  7. Known severe hypersensitivities to medical adhesives or hydrogel, or history of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study treatments used.
  8. Spinal cord compression not definitively treated with surgery and/or radiation.
  9. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
  10. Pregnant and lactating women
  11. Patients who have received brivudine, sorivudine or analogues 4 weeks prior to Fluoracile administration.

  12. Serious co-morbidities, including but not limited to:

    1. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree hart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse.
    2. History of cerebrovascular accident (CVA) within 3 months prior to randomization or that is not stable.
    3. Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.
    4. History of any psychiatric condition that might impair patient´s ability to understand or comply with the requirements of the study or to provide consent.

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

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