콘텐츠로 이동

전이성 췌장암 1차 치료로서 adebrelimab, decitabine, nab-paclitaxel, gemcitabine 병용 요법에 대한 제 1b/2상 임상시험

Phase Ib/II Clinical Study of Adebrelimab in Combination With Decitabine, Albumin-bound Paclitaxel, and Gemcitabine for the First-line Treatment of Metastatic Pancreatic 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 NCT06454448
상태 모집 중
단계 1상/2상
시험 약물/중재 Adebrelimab;decitabine;
대상 질환 Adebrelimab (SHR-1316), Decitabine, Metastatic Pancreatic Cancer
스폰서 Tianjin Medical University Cancer Institute and Hospital
연령·성별 18 Years ~ 75 Years · ALL
목표 인원 20
시작 / 1차 완료 예정 2024-06-15 / 2025-06
국내 실시기관 없음
실시 국가 1개국, 기관 1곳 (China)
결과 게시 아니오
최근 갱신 2024-06-28

시험 개요

이 임상시험은 전이성 췌장암(metastatic pancreatic cancer) 환자를 대상으로 adebrelimab, decitabine, albumin-bound paclitaxel(알부민 결합 파클리탁셀), gemcitabine(젬시타빈) 병용 요법의 유효성과 안전성을 평가하기 위한 전향적, 단일군, 단일기관 제1b/2상 임상시험입니다. 췌장암 환자 20명을 목표로 진행하며, 1차 평가변수는 용량제한독성(DLT), 권장 2상 용량(RP2D), 객관적 반응률(ORR)입니다. 면역관문억제제와 항암화학요법에 에피제네틱 억제제(decitabine)를 더해 면역치료 반응을 높이는 전략을 평가합니다.

  • 대상 질환은 조직학적으로 확진된 전이성 췌장암(AJCC 8판 기준 4기) 환자입니다.
  • 목표 환자 수는 20명입니다.
  • 1차 평가변수는 용량제한독성(DLT), 권장 2상 용량(RP2D), 객관적 반응률(ORR)입니다.
  • 2차 평가변수는 전체 생존기간(OS), 무진행 생존기간(PFS), 질병 통제율(DCR), 반응 지속기간(DoR), 안전성입니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 연령 18세에서 75세의 남성 또는 여성 - 췌장 도관 상피에서 기원한 조직학적 또는 세포학적으로 확진된 전이성 췌장암(AJCC 8판 기준 4기) - 이전 항암 치료를 받은 적이 없는 환자 - RECIST v1.1 기준에 따른 측정 가능한 표적 병변이 최소 1개 이상 존재 - ECOG 수행 능력 0~1 - 예상 생존기간 3개월 이상 - 주요 장기 기능이 양호한 환자 (호중구 1.510^9/L 이상, 혈소판 8010^9/L 이상, 혈색소 9g/dl 이상, 혈청 알부민 3g/dl 이상, 총 빌리루빈 1.5배 이하, ALT 및 AST 3배 이하 등) - 가임 여성의 임신테스트 음성 및 피임 동의, 남성 환자의 피임 동의 - 자발적 참여 및 동의서 서명 환자. 제외 기준: - 췌장 도관 상피 외의 기원인 췌장암(신경내분비암, 여포세포암, 모세포종, 고형 가유두종양 등) - 중추신경계 전이가 알려진 환자 - 심각한 위장관 기능 장애(출혈, 폐쇄, 2등급 초과 염증, 1등급 초과 설사) - 안정화되지 않은 제3공간 체액(대량 흉수 등) - 천자나 배액이 필요한 임상적 증상이 있는 복수 환자 - 현재 또는 과거 간질성 폐렴/폐질환 환자, 활동성 결핵 - 활동성 자가면역질환 또는 재발 가능성이 있는 자가면역질환 병력 - 말초신경병증(CTCAE 3등급 이상) - 무작위배정 전 4주 이내 심각한 감염(CTCAE 2등급 초과) - 무작위배정 전 면역억제제/전신 호르몬 치료, 방사선 치료, 대수술, 다른 임상시험 약물 투여를 받은 환자 - 비정상적 응고, 출혈 경향, 혈전용해 또는 항응고 치료 중인 환자 - 잘 조절되지 않는 심장 질환 환자

선정/제외 기준 원문 (영어)

Inclusion Criteria:

1. Age 18-75 years old, male or female; 2. Histologically or cytologically confirmed diagnosis of pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records showing metastatic pancreatic cancer (stage IV according to the AJCC 8th edition TNM staging of pancreatic cancer); 3. Have not received any anti-tumor therapy (including chemotherapy, targeted, immunotherapy, etc.); 4. Must have at least one measurable lesion as a target lesion (according to RECIST v1.1 criteria); the target lesion should not have received localized treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be selected as target lesions if progression is confirmed to have occurred and meets RECIST1.1 criteria); 5. ECOG: 0 to 1; 6. Expected survival ≥ 3 months; 7. Good major organ function, i.e., the following criteria are met (in the absence of receiving any blood components, cell growth factors within 14 days prior to randomization):

  1. Neutrophils ≥1.5*109/L; platelets ≥80*109/L; hemoglobin ≥9g/dl; serum albumin ≥3g/dl;
  2. Total bilirubin ≤ 1.5 times the upper limit of normal value (biliary obstruction allows biliary drainage); ALT and AST ≤ 3 times the upper limit of normal value (for patients with hepatic metastases, it can be relaxed to ≤ 5 times the upper limit of normal value);
  3. Serum creatinine ≤1.5 times the upper limit of normal value, creatinine clearance ≥50ml/min;
  4. INR ≤1.5 times the upper limit of normal value and APTT ≤1.5 times the upper limit of normal value (for the use of a stable dose of anticoagulation therapy, such as low molecular heparin or warfarin, and the INR is within the expected therapeutic range of anticoagulants can be screened);
  5. Electrocardiogram: QTcF ≤450ms (men), ≤470ms (women);
  6. Cardiac ultrasound: LVEF (left ventricular ejection fraction) ≥50%; 8. Women of childbearing potential must have had a negative blood pregnancy test within 3 days prior to randomization and be willing to use an appropriate method of contraception during the trial and for 6 months after completion of treatment. For men, this should be surgical sterilization or agreement to use an appropriate method of contraception for the duration of the study and for 3 months after completion of treatment; 9. Subjects voluntarily enroll in this study by signing an informed consent form.

Exclusion Criteria:

  1. patients with pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic follicular cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumors;
  2. patients with known central nervous system metastases;
  3. severe gastrointestinal dysfunction (with bleeding, obstruction; inflammation greater than grade 2; diarrhea greater than grade 1);
  4. the presence of third interstitial fluid (e.g., massive pleural fluid) that could not be stabilized (without interventional therapy after drain removal) except for ascites within 2 weeks before randomization;
  5. Patients with clinically symptomatic ascites who require puncture or drainage or who have received ascites drainage within the previous 3 months (except for imaging that shows only a small amount of ascites that is manageable but not accompanied by clinical symptoms);
  6. current concomitant interstitial pneumonia or interstitial lung disease, or a prior history of interstitial pneumonia or interstitial lung disease requiring hormonal therapy, or other pulmonary fibrosis that may interfere with the determination and management of immune-related pulmonary toxicity, mechanized pneumonia (e.g., occlusive bronchiectasis), pneumoconiosis, drug-associated pneumonitis, idiopathic pneumonitis, or active pneumonia or severely impaired pulmonary function as demonstrated by chest CT at the Screening Period Subjects; active tuberculosis;
  7. the presence of active autoimmune disease or a history of autoimmune disease with potential for relapse [including, but not limited to, autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (subjects who can be controlled by hormone replacement therapy only are eligible for enrollment)]; subjects who have a skin disease that does not require systemic treatment such as vitiligo, psoriasis, alopecia that Controlled type I diabetes mellitus receiving insulin therapy or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be enrolled;
  8. known peripheral neuropathy (CTCAE ≥ grade 3);
  9. a serious infection (CTCAE > grade 2) within 4 weeks prior to randomization, such as severe pneumonia, bacteremia, or complications of infection requiring hospitalization; signs and symptoms of infection requiring intravenous antibiotic therapy (except for prophylactic use of antibiotics) within 2 weeks prior to randomization;
  10. received any of the following treatments: 1) Immunosuppressive or systemic hormone therapy for immunosuppression within 2 weeks prior to randomization (dose >10 mg/day prednisone or other equipotent hormone); 2) Radiation therapy within 2 weeks prior to randomization; 3) Major surgery (e.g., open thoracic surgery, open abdominal surgery, etc.) within 4 weeks prior to randomization; 4) Received any other clinical study medication within 4 weeks prior to randomization, unless it was an observational (non-interventional) clinical study or an interventional clinical study follow-up.
  11. abnormal coagulation, bleeding tendency or undergoing thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (≤100mg/day), low molecular heparin (enoxaparin 40mg/day and other low molecular heparin at its equivalent dose) is allowed;
  12. patients with cardiac clinical conditions or diseases that are not well controlled, such as (1) NYHA class 2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 6 months, and (4) clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention;
  13. malignancy other than pancreatic cancer within 5 years prior to randomization, with the exception of adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell carcinoma of the skin;
  14. known hypersensitivity to PD-L1, albumin paclitaxel, gemcitabine, decitabine, and any of the components of the above products;
  15. known to have acquired immunodeficiency syndrome (AIDS) or HIV test positive, active syphilis infection;
  16. previous history of definite neurological or psychiatric disorders, including epilepsy or dementia;
  17. Subjects who, in the judgment of the investigator, have other factors that may cause them to be forced to terminate the study midway, such as non-compliance with the protocol, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, grossly abnormal values of clinically significant laboratory tests, familial or social factors that may affect the safety of the subject or the collection of trial data.

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.