국소 진행성 췌장관선암 환자에서 수술 전 면역항암제와 방사선 치료를 병용하는 2상 임상시험¶

Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma

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	NCT06048484
상태	모집 중
단계	2상
시험 약물/중재	Stereotactic body radiotherapy (SBRT), Zimberelimab, Quemliclustat, Etrumadenant, Modified FOLFIRINOX
대상 질환	Pancreatic Ductal Adenocarcinoma
스폰서	Gulam Manji
연령·성별	18 Years ~ 제한 없음 · ALL
목표 인원	60
시작 / 1차 완료 예정	2024-05-10 / 2027-04
국내 실시기관	없음
실시 국가	1개국, 기관 5곳 (United States)
결과 게시	아니오
최근 갱신	2026-02-27

문의처 (등록된 중앙 연락처)¶

Research Nurse Navigator 212-342-5162 cancerclinicaltrials@cumc.columbia.edu

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

시험 개요¶

이 연구는 국소 진행성 췌장관선암(Pancreatic Ductal Adenocarcinoma) 환자를 대상으로 수술 전 표준 방사선 치료(Stereotactic body radiotherapy, SBRT)와 면역항암제 zimberelimab, CD73 억제제 quemliclustat, A2a/b 억제제 etrumadenant의 병용 투여 안전성과 면역 반응 증가 효과를 평가하는 2상 임상시험입니다. 총 60명의 환자를 목표로 진행되며 1단계와 2단계로 나누어 환자들에게 수술 전 7주간 치료를 시행합니다. 초록에 최종 임상 결과 및 생존기간 수치는 명시되지 않았습니다.

대상 질환은 국소 진행성 췌장관선암(Pancreatic Ductal Adenocarcinoma)이며 목표 인원은 60명입니다.
수술 전 7주 동안 SBRT와 함께 zimberelimab, quemliclustat, etrumadenant 등의 약물 병용 치료를 시험합니다.
효과 및 생존율 수치는 초록에 명시되지 않았습니다.

참여 조건 (AI 정리, 원문 확인 필요)¶

선정 기준: - 췌장관선암(PDAC)의 조직학적 또는 병리학적 확진 - 8주기의 선행화학요법(neoadjuvant modified FOLFIRINOX) 완료 - 수술적 절제가 가능하고 해당 수술에 적합한 환자 - SBRT 치료가 가능한 환자 - 고형암 반응평가기준(RECIST) 1.1에 따른 측정 가능한 병변 존재 - mFOLFIRINOX 외에 췌장암에 대한 이전 수술, 전신 치료, 방사선 치료력이 없는 경우 - 미국동부종양학협회(ECOG) 수행능력 상태가 0 또는 1인 환자 - 18세 이상

제외 기준: - 항 CTLA-4, 항 PD-1, 항 PD-L1 등 T세포 공동자극 또는 면역관문 억제 치료를 받은 이력이 있는 환자 - 다른 임상시험용 약물을 동시에 투여받고 있는 환자 - 조절되지 않는 흉수, 심낭수, 복수가 있는 환자 - 자가면역 질환 또는 면역 결핍의 활성 또는 병력이 있는 환자 - 임산부 및 수유부

선정/제외 기준 원문 (영어)

Inclusion Criteria:

Histological or pathological confirmation of pancreatic adenocarcinoma Cytologic or histologic proof of pancreatic ductal adenocarcinoma (PDAC) needs to be verified by the treating institution pathologist. A pathological report from non-treating institutions is sufficient to consent and to initiate investigational therapy if tissue sample is unavailable for evaluation at time of consent or enrollment. However, in such a case, PDAC diagnosis should be confirmed by the treating institution pathologist at a later time.
Completed 8 cycles of neoadjuvant modified FOLFIRINOX. Omission of oxaliplatin due to adverse events may be allowed in cycles 5-8 with consultation with the principal investigator.
Patients with surgically resectable PDAC who are considered appropriate to undergo the applicable operation.
Eligible to undergo SBRT.
Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
No prior surgical, systemic, or radiotherapy for PDAC except for mFOLFIRINOX.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Age ≥ 18 years.
Adequate hematological and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of investigational treatment:

Exclusion Criteria:

Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
Patients who are receiving any other investigational agents concurrently.
Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable).
Uncontrolled pleural effusion, pericardial effusion, or ascites.
Uncontrolled hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL, or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy.
Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (Crohn's disease or ulcerative colitis), antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis (some exceptions permissible as outlined per protocol).
History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.

• History of radiation pneumonitis in the radiation field (fibrosis) is permitted. * Positive HIV test at screening or at any time prior to screening. * Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening.

--Note: Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody test at screening, are eligible for the study. * Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test. * Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, fatty liver disease, and inherited liver disease. * Known active tuberculosis. * Inability to swallow medication or malabsorption condition that would alter the absorption of orally administered medications. * Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents and breastfeeding should be discontinued. * History of allergy or hypersensitivity to oxaliplatin, irinotecan, leucovorin, fluorouracil, pegfilgrastim, or any excipients. * History of Gilbert's disease or known genotype UGT1A1 *28/*28. * Inflammatory disease of the colon or rectum, or severe uncontrolled diarrhea. * Active or history of celiac disease. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

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.