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수술 전 절제 가능 및 경계성 절제 가능 췌장암 치료를 위한 Gemcitabine, Nab-paclitaxel, Durvalumab 및 Oleclumab 병용 임상 2상 시험

Gemcitabine, Nab-paclitaxel, Durvalumab, and Oleclumab Before Surgery for the Treatment of in Resectable/Borderline Resectable Primary 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 NCT04940286
상태 진행 중(모집 종료)
단계 2상
시험 약물/중재 Durvalumab, Gemcitabine, Nab-paclitaxel, Oleclumab
대상 질환 Borderline Resectable Pancreatic Adenocarcinoma, Resectable Pancreatic Adenocarcinoma, Stage IA Pancreatic Cancer AJCC v8, Stage IB Pancreatic Cancer AJCC v8, Stage IIA Pancreatic Cancer AJCC v8, Stage IIB Pancreatic Cancer AJCC v8
스폰서 M.D. Anderson Cancer Center
연령·성별 18 Years ~ 제한 없음 · ALL
목표 인원 13
시작 / 1차 완료 예정 2021-09-28 / 2027-10-30
국내 실시기관 없음
실시 국가 1개국, 기관 1곳 (United States)
결과 게시 아니오
최근 갱신 2026-10-07

시험 개요

이 임상 2상 시험은 수술로 절제가 가능하거나 경계성 절제 가능(borderline resectable) 상태인 원발성 췌장암 환자를 대상으로 수술 전 병용 치료의 효과를 평가합니다. 환자들은 항암화학요법(gemcitabine, nab-paclitaxel)과 면역항암제(durvalumab, oleclumab)를 병용 투여받은 후 수술을 진행하게 됩니다. 주요 목표는 절제된 종양 조직 내 살아있는 암세포가 5% 이하인 주요 병리학적 반응률(MPR)과 해당 병용요법의 안전성을 평가하는 것입니다.

  • 수술 전 보조요법으로서 면역항암제(durvalumab, oleclumab)와 세포독성항암제(gemcitabine, nab-paclitaxel)의 4제 병용요법을 2~6주기 투여합니다.
  • 일차 목표는 생존 종양 세포 5% 이하를 의미하는 주요 병리학적 반응(MPR) 비율 및 수술 전 치료의 안전성 확인입니다.
  • 수술 후에는 담당 의사의 판단에 따라 durvalumab/oleclumab 병용, 항암화학요법 추가 또는 추적 관찰을 진행합니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: * 만 18세 이상의 성인 환자 * 조직학적 또는 세포학적으로 확인된 절제 가능 또는 경계성 절제 가능 췌장 선암종 * 이전에 췌장 선암종에 대한 항암 치료를 받은 적이 없는 환자 * ECOG 수행 상태(PS) 0~1점 * 적절한 골수, 간 및 신장 기능(절대 호중구 수 1,500/mm³ 이상, 혈소판 100,000/mm³ 이상, 혈색소 9.0 g/dL 이상 등) * 예상 기대 여명이 최소 6개월 이상인 환자

제외 기준: * 영상학적으로 확인된 명백한 원격 전이 병변이 있는 환자 * 수술 전 방사선 치료가 필요할 것으로 판단되는 환자 * 첫 투약 전 4주 이내에 다른 시험용 의약품 임상시험에 참여한 환자 * 첫 투약 전 28일 이내에 주요 수술을 받은 환자 * 동종 장기 이식의 병력이 있는 환자 * 활동성 또는 과거 자가면역 질환/염증성 질환 병력이 있는 환자(백반증, 탈모증, 갑상선기능저하증 등 일부 예외 제외)

선정/제외 기준 원문 (영어)

Inclusion Criteria:

  • Capable of giving written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent includes any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
  • Age >= 18 years at time of study entry
  • Has histologically or cytologically confirmed resectable or borderline resectable pancreatic adenocarcinoma per MD Anderson criteria (borderline patients based upon reconstructable superior mesenteric vein/portal vein [SMV/PV] involvement or reconstructable hepatic artery involvement are allowed)
  • Has received no prior anti-cancer therapy for pancreatic adenocarcinoma
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Hemoglobin >= 9.0 g/dL
  • Absolute neutrophil count 1.5 x (>= 1500 per mm\^3)
  • Platelet count >=100 x 10\^9/L (>= 100,000 per mm\^3)
  • Serum bilirubin =\< 1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician. Subjects requiring biliary decompression, biliary stent, or drainage using percutaneous trans-hepatic cholangiogram are allowed (patients with a declining bilirubin status post stent placement are eligible with serum bilirubin =\< 2.5 x institutional ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =\< 2.5 x institutional ULN
  • Measured creatinine clearance (CL) > 40 mL/min or calculated creatinine CL> 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance

  • Has evidence of post-menopausal status or negative urinary- or serum pregnancy test for female, pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:

  • Women \< 50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or if they underwent surgical sterilization (bilateral oophorectomy or hysterectomy).

  • Women >= 50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
  • Is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up
  • Must have a predicted life expectancy of at least 6 months
  • Is willing to undergo mandatory research esophagogastroduodenoscopy/endoscopic ultrasound for fine-needle aspiration (exceptions to this eligibility can be discussed with principal investigator [PI] and will be considered on a case-by-case basis)
  • Has body weight of > 35 kg

Exclusion Criteria:

  • Participated in another clinical study with an investigational product during the last 4 weeks from the first dose of this study's treatment
  • May need preoperative radiation therapy (as determined per the treating medical team: medical oncologist and/or surgical oncologist at time of study enrollment)
  • Is concurrently enrolled in another clinical study (patient is eligible if the study is an observational (non interventional) study or if enrollment is during the follow-up period of an interventional study
  • Has definitive evidence of metastatic disease per radiographic assessment
  • Is receiving any concurrent chemotherapy, investigational product (IP), or biologic- or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
  • Had a major surgical procedure within 28 days prior to the first dose of IP (PORT placement does not count; if classification is uncertain, discuss with PI)
  • Has history of allogenic organ transplantation

  • Has an active or previously documented autoimmune or inflammatory disorder (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [diverticulosis is not an excluding factor], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion (and do not exclude patients from participation):

  • Patients with vitiligo or alopecia

  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
  • Patients having any chronic skin condition that does not require systemic therapy
  • Patients without active disease in the last 5 years (allowed only after consultation with the study physician)
  • Patients with celiac disease controlled by diet alone
  • Has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection; symptomatic congestive heart failure; uncontrolled hypertension; unstable angina pectoris; cardiac arrhythmia; interstitial lung disease; serious chronic gastrointestinal conditions associated with diarrhea; or psychiatric illness/social situations that would limit compliance with study requirements, would substantially increase risk of incurring adverse events (AEs), or would compromise the ability of the patient to give written informed consent

  • Has a history of another primary malignancy. Patients having the following are still eligible:

  • Malignancy treated with curative intent, no known active disease >= 5 years before the first dose of IP, and low potential risk for recurrence

  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease
  • Has a history of leptomeningeal carcinomatosis
  • Has a history of active primary immunodeficiency
  • Has active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (hepatitis C virus [HCV]) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)

  • Is currently using or previously used immunosuppressive medication within 14 days before the first dose of durvalumab. The following medications are exceptions to this criterion:

  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)

  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication)
  • Has received live attenuated vaccine within 30 days prior to the first dose of IP. Note: patients, if enrolled, should not receive live vaccine while receiving IP or during the 30 days after the last dose of IP
  • Is a female and pregnant or breastfeeding; or is a male or female of reproductive potential who is not willing to employ effective birth control from time of screening to 90 days after the last dose of durvalumab and oleclumab monotherapy
  • Has a known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
  • Previously received clinical-trial treatment with durvalumab or oleclumab regardless of treatment arm assignment
  • Has laboratory evidence of hypercalcemia (>= 11 mg/dL [in presence of normal albumin]) and/or hyperphosphatemia (>= 5.5 mg/dL)
  • Has a history of venous thrombosis within the past 3 months prior to scheduled first dose of study treatment and is not receiving fully dosed anticoagulation; or has symptomatic venous thrombosis and symptoms have not improved
  • Has a prior history of myocardial infarction, transient ischemic attack, or stroke within the past 3 months prior to the scheduled first dose of study treatment
  • Is unsuitable to participate in the study or is unlikely to comply with study procedures, restrictions and requirements (per judgment by the investigator)

출처: ClinicalTrials.gov · 수집 2026-10-08 · 갱신 2026-10-08

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