콘텐츠로 이동

전이성 암 환자를 위한 종양 침윤 림프구(TIL)를 이용한 면역요법

Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic 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 NCT01174121
상태 모집 중
단계 2상
시험 약물/중재 Pembrolizumab (Keytruda), Fludarabine, Cyclophosphamide, Aldesleukin, Young TIL
대상 질환 Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer, Metastatic Ovarian Cancer, Metastatic Breast Carcinoma, Metastatic Endocrine Tumors/ Neuroendocrine Tumors
스폰서 National Cancer Institute (NCI)
연령·성별 18 Years ~ 72 Years · ALL
목표 인원 332
시작 / 1차 완료 예정 2010-08-26 / 2028-12-27
국내 실시기관 없음
실시 국가 1개국, 기관 1곳 (United States)
결과 게시 아니오
최근 갱신 2026-10-02

문의처 (등록된 중앙 연락처)

  • NCI/Surgery Branch Recruitment Center (866) 820-4505 IRC@nih.gov

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

시험 개요

본 임상시험은 표준 화학요법에 반응하지 않는 전이성 췌장암을 포함한 전이성 고형암 환자를 대상으로 합니다. 환자의 종양에서 추출해 배양한 종양 침윤 림프구(TIL, Tumor Infiltrating Lymphocytes) 세포치료제와 면역관문억제제 pembrolizumab(펨브롤리주맙, 상품명 Keytruda)의 병용 치료 안전성과 유효성을 평가합니다. 림프구 소모성 전처치 요법과 고용량 aldesleukin(알데스류킨)을 함께 투여하여 종양 축소 효과를 확인하는 2상 임상시험입니다.

  • 목표 환자 수는 최대 332명이며 췌장암을 포함한 전이성 소화기암 환자 등이 참여 대상입니다.
  • 자가 종양 침윤 림프구(autologous TIL)와 pembrolizumab, 고용량 aldesleukin을 병용합니다.
  • 초록에 구체적인 생존기간이나 객관적 반응률(ORR) 결과는 아직 명시되지 않았습니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 표준 전신 치료에 불응성인 전이성 상·하부 위장관암, 간담도암, 비뇨기생식기암, 유방암, 난소/자궁내막암, 신경내분비종양 등을 포함한 전이성 암 환자 - 연령 만 18세 이상 만 72세 이하 - ECOG 수행 능력 평가 0 또는 1 - TIL 생산을 위해 최소 침습 수술 등으로 절제 가능한 병소가 적어도 1개 이상 존재 - HIV, B형간염, C형간염 음성 - 적절한 조혈모세포 및 간·신장 기능 유지 제외 기준: - 임신 중이거나 수유 중인 환자 - 동종 전신 스테로이드 치료를 받는 환자 - 항감염 치료가 필요한 활성 전신 감염 또는 조혈 장애 - 원발 부위의 폐쇄, 천공, 출혈 위험이 있는 진행된 상태 - 일차성 면역결핍증 또는 주요 장기 자가면역질환 병력 - cyclophosphamide, fludarabine, aldesleukin에 대한 중증 과민반응 병력 - 관상동맥 재개통술 또는 허혈성 증상 병력

선정/제외 기준 원문 (영어)
  • INCLUSION CRITERIA:
  • Measurable (per RECIST v1.0 criteria), metastatic cancer of one of the following types: upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial, or endocrine tumors including neuroendocrine tumors. Patients must have at least one lesion that is resectable for TIL generation with minimal morbidity, preferentially using minimal invasive laparoscopic or thoracoscopic surgery for removal of superficial tumor deposit.
  • Confirmation of diagnosis of metastatic cancer by the NCI Laboratory of Pathology.

  • Refractory to approved standard systemic therapy. Specifically:

  • Patients with metastatic colorectal cancer must have received oxaliplatin or irinotecan.

  • Patients with hepatocellular carcinoma must have received sorafenib (Nexavar(R)), since level 1 data support a survival benefit with this agent.
  • Patients with breast and ovarian cancer must be refractory to both first- and second-line treatments and must have received at least one second-line chemotherapy regimen.
  • Patients with 3 or fewer brain metastases that are \< 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
  • Age greater than or equal to 18 years and less than or equal to 72 years.
  • Clinical performance status of ECOG 0 or 1.
  • Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and 12 months after the last dose of combined chemotherapy for individuals of child-bearing potential (IOCBP) and for four months after treatment for individuals that can father children.
  • IOCBP must have a negative pregnancy test be a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.

Serology

  • Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)
  • Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.

Hematology

  • ANC > 1000/mm\^3 without the support of filgrastim
  • WBC greater than or equal to 2500/mm\^3
  • Platelet count greater than or equal to 80,000/mm\^3
  • Hemoglobin > 8.0 g/dL. Subjects may be transfused to reach this cut-off.

Chemistry

  • Serum ALT/AST less than or equal to 5.0 x ULN
  • Serum creatinine less than or equal to 1.5 x ULN
  • Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert s Syndrome, who must have a total bilirubin \< 3.0 mg/dL.
  • Patients must have completed any prior systemic therapy at the time of enrollment.

Note: Patients may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to less than or equal to grade 1.

  • Ability of subject to understand and the willingness to sign a written informed consent document.
  • Willing to sign a durable power of attorney.
  • Subjects must be co-enrolled on protocol 03-C-0277.

EXCLUSION CRITERIA:

  • Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.
  • Concurrent systemic steroid therapy.
  • Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.
  • Advanced primary with impeding occlusion, perforation or bleeding, dependent on transfusion.
  • Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
  • History of major organ autoimmune disease.
  • Grade 3 or 4 major organ irAEs clinically attributed to anti-PD-1/PD-L1 therapy.
  • Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immunecompetence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
  • History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.
  • History of coronary revascularization or ischemic symptoms.
  • For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.
  • Documented Child-Pugh score of B or C for hepatocellular carcinoma patients with known underlying liver dysfunction.
  • For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50%.
  • Patients who are receiving any other investigational agents.

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

댓글 기능은 아직 설정 전입니다 (관리자: docs/SETUP.md의 giscus 항목 참고). 의견은 GitHub Discussions에 남겨 주세요.