진행성 췌장암 1차 치료로서 변형 FOLFIRINOX 유지 치료 대 젬시타빈+냅-파클리탁셀 전환 유지 치료를 비교하는 임상시험

Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherapy in Patients With Advanced Pancreatic Cancer.

안내

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항목	내용
등록번호	NCT06897644
상태	모집 중
단계	3상
시험 약물/중재	Oxaliplatin, Irinotecan (CPT-11), Leucovorin, 5-FU (5-fluorouracil), gemcitabine, Nab-paclitaxel
대상 질환	Pancreatic Adenocarcinoma Advanced or Metastatic
스폰서	Gruppo Oncologico del Nord-Ovest
연령·성별	18 Years ~ 제한 없음 · ALL
목표 인원	340
시작 / 1차 완료 예정	2025-03-27 / 2029-01-01
국내 실시기관	없음
실시 국가	1개국, 기관 28곳 (Italy)
결과 게시	아니오
최근 갱신	2026-09-09

문의처 (등록된 중앙 연락처)

• Monica Niger, MD +3902 2390 2919 monica.niger@istitutotumori.mi.it

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

시험 개요

이 임상시험(PANThEON)은 절제 불가능한 국소 진행성 또는 전이성 췌장암 환자를 대상으로 합니다. 유도 FOLFIRINOX 항암 치료를 3개월 동안 진행한 후 질병이 진행되지 않은 환자를 무작위로 배정합니다. A군은 FOLFIRINOX 유지 치료를 계속하고, B군은 gemcitabine(젬시타빈)과 nab-paclitaxel(냅-파클리탁셀)로 전환하여 유지 치료를 받습니다. 전체 생존기간(OS)을 비교하는 것이 목표입니다.

• 목표 환자 수는 총 340명입니다.
• 유도 FOLFIRINOX 치료를 최대 14주(약 6주기) 동안 시행합니다.
• 완전 반응, 부분 반응, 안정 병변 또는 비진행성 질환을 보인 환자를 1:1 비율로 무작위 배정합니다.
• 1차 평가지표는 전체 생존기간(OS)입니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 서면 동의서를 제공할 수 있고 연구 프로토콜을 준수할 수 있는 환자 - 18세 이상의 성인 - 조직학적 또는 세포학적으로 확진된, 1차 치료 대상인 절제 불가능한 국소 진행성 또는 전이성 췌장담관암(췌장 선암) - RECIST 1.1 기준에 따른 측정 가능 또는 측정 불가능한 병변의 존재 - 바이오마커 분석을 위한 보관된 종양 검체(원발성 종양 또는 전이 부위) 확보 가능 - ECOG 수행 능력 평가(PS) 0-1 (70세 미만인 경우), 70세 이상인 경우는 ECOG PS 0 필수 - 예상 기대 여명 3개월 초과 - 적절한 골수, 간, 신장 및 응고 기능 기준 충족 (호중구 수, 혈소판, 헤모글로빈, 빌리루빈, 크레아티닌 등 기준 충족 필요) - 완전한 디히드로피리미딘 탈수소효소(DPYD) 효소 결핍이 없을 것 - 임신 가능성이 있는 여성 및 남성은 연구 기간 및 마지막 치료 후 최소 7개월 동안 피임 방법에 동의해야 함

제외 기준: - 췌장 신경내분비종양, 선방세포종, 편평상피세포/선편평상피세포종, 또는 도세포종 - 진행성 췌장선암에 대해 이전에 또는 동시에 받은 전신 치료(세포독성 약물, 표적 치료제, 기타 임상시험용 약물)력이 있는 경우 (단, 완치 목적의 수술과 연관된 이전 보조요법/신보조요법은 마지막 치료 후 9개월이 지난 경우 허용) - 무작위 배정 전 4주 이내에 시행한 주요 수술 또는 방사선 치료 - 이전 치료로 인한 CTCAE 2등급 이상의 해결되지 않은 독성 - 증상이 있거나 치료가 필요한 중추신경계(CNS) 전이 - 다른 활성 악성 종양의 병력 또는 진행 중인 악성 종양 (치료된 기저세포암, 자궁경부 상피내암, 전립선암 제외) - 조절되지 않는 활동성 B형 또는 C형 간염, HIV 감염 - 임신 중이거나 모유 수유 중인 환자

선정/제외 기준 원문 (영어)

Inclusion Criteria:

• Patient able and willing to provide written informed consent and to comply with the study protocol.
• Subjects must be ≥18 years.
• Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic adenocarcinoma eligible for treatment in the first-line setting.
• Presence of measurable or non-measurable disease assessed by CT scan and/or MRI according to RECIST 1.1. Note: any lesion which has been subjected to percutaneous therapies or radiotherapy should not be considered measurable, unless the lesion has clearly progressed since the procedure.
• Availability of archival tumor sample (primary tumor or metastatic site) for biomarker analysis.
• ECOG performance status of 0-1 (if age \< 70 years). If age ≥70 years, ECOG PS must be 0.
• Estimated life expectancy > 3 months.

• Adequate baseline hematologic function characterized by the following at screening:

• Absolute Neutrophil Count (ANC) ≥ 1.5 × 109/L.

• Platelets count ≥ 100 × 109/L.
• Hemoglobin ≥ 9 g/dl. Note: prior transfusions for patients with low hemoglobin are allowed.

• Adequate liver function characterized by the following at screening:

• Serum total bilirubin ≤ 1.5 × ULN and \< 2 mg/dL. Note: Subjects with Serum total bilirubin ≥ 1.5 × ULN and conjugated bilirubin ≤ ULN or \< 40% of total bilirubin are allowed.

• Serum transaminases (AST and/or ALT) \< 3 x ULN (\< 5 x ULN in presence of liver metastasis). In participants with elevated AST or ALT, the values must be stable for at least 2 week and with no evidence of biliary obstruction by imaging.
• Adequate renal function, i.e. serum creatinine ≤ 1.5 x institutional ULN and calculated by Cockroft-Gault formula or directly measured creatinine clearance ≥ 50 mL/min.
• Adequate coagulation functions as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy).
• No presence of complete dihydropyrimidine dehydrogenase (DPYD) enzyme deficiency (homozygous of the following DPYD polymorphisms: c1679GG, c1905+1AA, c2846TT) with DPYD gene testing mandatory at screening as per national guidelines. UDP-glucuronosyltransferase 1A1 (UGT1A1) testing is not mandatory. However, if UGT test is routinely performed in the participating centers, enrolment of patients carriers of variants of DPYD and homozygous variant UGT1A1 [7/7] has to be discussed with the Sponsor.
• Women of childbearing potential must agree to remain abstinent (refrain from sexual intercourse) or use highly effective contraceptive methods, as defined in APPENDIX V of the full protocol, during the treatment period and for at least 7 months after the last administration of study treatments.
• Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women \<1 year after the onset of menopause.
• Men must agree to remain abstinent (refrain from sexual intercourse) or use highly effective contraceptive methods during the treatment period and for at least 7 months after the last administration of study treatments.
• Participants must agree not to donate eggs/sperm for future use for the purposes of assisted reproduction during the study and for a period of 7 months after receiving the last dose of study treatment. Female and male participants should consider preservation of eggs/sperm prior to study treatment as anti-cancer treatments may impair fertility.

Exclusion Criteria:

• Pancreatic neuroendocrine, acinar, squamous/adenosquamous, or islet tumors.
• Previous or concurrent systemic (e.g. cytotoxic or targeted or other experimental drugs) therapy for advanced pancreatic adenocarcinoma.

Note: previous (neo)adjuvant or perioperative anti-cancer therapy for non-metastatic, resectable or borderline resectable PDAC, associated with surgery on the primary tumor, is allowed if > 9 months have elapsed from the last dose of therapy and documented disease progression or relapse.

• Major surgery or radiation therapy performed within \<4 weeks before randomization. Palliative radiotherapy to bone lesions is allowed if performed > 2 weeks prior to start of study treatment. Patients must have recovered from an effect from major surgery.
• Known allergy or hypersensitivity to study drugs and/or their excipients.
• Unresolved toxicity ≥ CTCAE grade 2 attributed to any prior therapies (e.g. grade ≥2 peripheral neurotoxicity), excluding anemia or alopecia.
• Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that requires directed therapy (such as radiotherapy or surgery) or increasing doses of corticosteroids 2 weeks prior to study entry. Participants with treated symptomatic brain metastases should be neurologically stable for 4 weeks post-treatment and prior to study entry.
• Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years prior to study entry except for curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, and prostate cancer.
• Know active uncontrolled hepatitis B or hepatitis C. Patients with a past or resolved HBV infection are eligible. Patients with chronic disease controlled by antiviral therapy or requiring prophylactic treatment are eligible.
• Chronic or current active infectious disease requiring systemic antibiotics or antifungal treatment within 2 weeks prior to enrollment.
• Known uncontrolled HIV infection. HIV-positive patients are eligible if their CD4+ cell count amounts to 300 cells per μL or more; HIV viral load must be undetectable per standard of care assay, and patients must be compliant with antiretroviral treatment.
• Pregnant or breast-feeding patient, or patient planning to become pregnant within 7 months after the end of treatment.
• Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA > II, unstable angina pectoris, history of myocardial infarction within 3 months before study entry, significant arrhythmia).
• Presence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent.
• Any serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial.

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

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