KRAS 변이가 없는 절제 불가능 또는 전이성 췌장암에서 파니투무맙 병용 화학요법에 대한 3상 임상시험¶

Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations

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	NCT06998940
상태	모집 중
단계	3상
시험 약물/중재	Biospecimen Collection, Computed Tomography, Fluorouracil, Gemcitabine, Irinotecan, Irinotecan Sucrosofate, Leucovorin, Nab-paclitaxel, Panitumumab, Questionnaire Administration
대상 질환	Locally Advanced Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Pancreatic Adenocarcinoma
스폰서	SWOG Cancer Research Network
연령·성별	18 Years ~ 제한 없음 · ALL
목표 인원	94
시작 / 1차 완료 예정	2026-05-13 / 2029-12-31
국내 실시기관	없음
실시 국가	1개국, 기관 274곳 (United States)
결과 게시	아니오
최근 갱신	2026-05-22

시험 개요¶

이 3상 임상시험은 KRAS 야생형(wild type, WT) 국소 진행성 또는 전이성 췌관선암(pancreatic ductal adenocarcinoma) 환자를 대상으로 표준 세포독성 항암화학요법에 panitumumab(파니투무맙)을 추가하는 치료의 효과를 평가합니다. 참여 환자들은 무작위로 파니투무맙 병용 치료군(A군) 또는 표준 항암화학요법 단독 치료군(B군)으로 배정됩니다. 주요 목표는 두 군 간의 전체 생존기간(Overall Survival, OS)을 비교하는 것이며, 무진행 생존기간(Progression-Free Survival, PFS), 객관적 반응률(Overall Response Rate, ORR), 삶의 질 등을 이차 목표로 평가합니다. 총 목표 환자 수는 94명입니다.

KRAS 야생형 절제 불가능 또는 전이성 췌장암 환자 94명을 대상으로 하는 3상 임상시험입니다.
표준 항암화학요법(5-FU 또는 젬시타빈 기반)에 panitumumab을 추가했을 때의 전체 생존기간(OS)과 무진행 생존기간(PFS)을 비교합니다.
이차 목표로 객관적 반응률(ORR), 질병 통제률(DCR), 독성 발생 빈도 및 환자 보고 삶의 질(QOL)을 평가합니다.

참여 조건 (AI 정리, 원문 확인 필요)¶

선정 기준:- 췌장의 췌관선암으로 조직학적 또는 세포학적으로 확진된 환자- 종양 조직 기반의 NGS 검사를 통해 KRAS 야생형 및 BRAF V600E 야생형임이 확인된 환자 (혈액 기반 NGS 검사는 인정되지 않음)- CT 또는 MRI를 통해 절제 불가능 및/또는 전이성 병기가 확인된 환자- 국소 진행성 또는 전이성 췌관선암에 대해 1차 전신 세포독성 항암화학요법을 받았고 이에 대해 방사학적 진행, 불응, 또는 불내성을 보인 환자- 만 18세 이상- Zubrod 전신 수행 능력 상태 0~2인 환자- 절대호중구수(ANC) 1.0 x 10^3/uL 이상, 혈색소 8 g/dL 이상인 환자. 제외 기준:- 뇌 전이 또는 두개골 경막 외 질환이 있으면서 방사선 치료 및/또는 수술로 적절히 치료되지 않았거나 무작위 배정 전 28일 이내에 안정화되지 않은 환자- 항-EGFR 항체(예: cetuximab 또는 panitumumab) 치료 경험이 있는 환자- EGFR 티로신 키나제 억제제(예: erlotinib) 치료 경험이 있는 환자- 무작위 배정 전 14일 이내에 췌장 항암 치료(표준 치료 또는 임상시험용 약물 등)를 받은 환자

선정/제외 기준 원문 (영어)

Inclusion Criteria:

Participants must have a histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of the pancreas
Participants must have previously documented KRAS wild type (i.e. absence of any KRAS mutation) and BRAF V600E wild type (i.e. absence of a BRAF V600E mutation) status determined by tumor tissue-based NGS assay. The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification status
NOTE: Blood-based next generation sequencing (NGS) assays, such as circulating tumor deoxyribonucleic acid (DNA) (ctDNA) or liquid biopsies, will not be accepted for meeting eligibility criteria
Participants must have documented unresectable and/or metastatic disease on CT or magnetic resonance imaging (MRI) imaging completed prior to randomization. Imaging must have been completed within 28 days prior to randomization for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Participants must not have known mutations in PTEN, NRAS, EGFR extracellular domain exons 1-16, no amplifications of HER2 and MET, and no gene fusions of RET, NTRK1, and ALK by tumor tissue-based NGS analysis
NOTE: Participants who are not tested for these mutations are eligible if they have previously documented KRAS wild type (i.e. absence of any KRAS mutation) and BRAF V600E wild type (i.e. absence of a BRAF V600E mutation) status
Participants must not have known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 28 days before randomization (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day).
NOTE: Participants must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment
Participants must have received only one line of prior systemic cytotoxic chemotherapy for locally advanced or metastatic PDA, and have radiographically progressed, refractory, or intolerant to this therapy.
Prior neoadjuvant or adjuvant therapy with 5-FU or gemcitabine-based chemotherapy counts as a line of therapy if the participant's disease progressed to locally advanced or metastatic disease within 6 months of completing treatment
Participants with cancers harboring molecular alterations including microsatellite instability (MSI-high), elevated tumor mutational burden (TMB) (TMB ≥ 10 mut/Mb), and FGFR1-3, NRG1, and ROS fusions are allowed to have received an additional line of targeted therapy applicable to the respective molecular alterations at the treating investigators discretion.
Prior maintenance therapy with Olaparib or Rucaparib for germline or somatic BRCA1/2 or PALB2 mutations does not count as a line of therapy.
Participants must not have prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab)
Participants must not have prior treatment with an EGFR tyrosine kinase inhibitor (e.g., erlotinib)
Participants must not have received any pancreatic anticancer therapy (e.g., standard of care or investigational chemotherapy, molecularly targeted therapy, or radiation) within 14 days prior to randomization
Participants must not have a known contraindication to receiving chosen chemotherapy backbone at the planned doses in accordance with the local approved label
Participant must be ≥ 18 years old at the time of randomization
Participants must have Zubrod performance status of 0-2
Participants must have a complete medical history and physical exam within 28 days prior to randomization (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Absolute neutrophil count ≥ 1.0 x 10\^3/uL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Note: Use of growth factor support (e.g., Granulocyte Colony-Stimulating Factor [G-CSF] or romiplostim [Nplate]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed
Hemoglobin ≥ 8 g/dL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Note: Use of growth factor support (e.g., G-CSF or romiplostim [Nplate]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed
Platelets ≥ 75 x 10\^3/uL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Note: Use of growth factor support (e.g., G-CSF or romiplostim [Nplate]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed
Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Aspartate aminotransferase (AST) ≤ 10 x upper limits of normal (ULN) (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Participants must have a creatinine ≤ the IULN OR measured OR calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
Participants with known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization
Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated
Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated
Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
Participants must be offered the opportunity to participate in specimen banking
Participants who can complete patient reported outcomes (FACT-G and PRO-CTCAE) questionnaires in English or Spanish must be offered the opportunity to participate in the quality-of-life studies
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

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

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