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절제 불가능한 췌장암 환자의 1차 치료로서 Retlirafusp Alfa, Famitinib, Nab-Paclitaxel, Gemcitabine 병용 요법

Retlirafusp Alfa Combined With Famitinib, Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Unresectable 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 NCT07814859
상태 모집 예정
단계 2상
시험 약물/중재 Retlirafusp alfa Injection, Famitinib, AG
대상 질환 Pancreatic Cancer
스폰서 The First Affiliated Hospital of Zhengzhou University
연령·성별 18 Years ~ 80 Years · ALL
목표 인원 88
시작 / 1차 완료 예정 2026-08-31 / 2027-08-31
국내 실시기관 없음
실시 국가 1개국, 기관 1곳 (China)
결과 게시 아니오
최근 갱신 2026-09-11

문의처 (등록된 중앙 연락처)

  • Zhai Wenlong Chief Physician 13937150977 zhai-wl@hotmail.com

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

시험 개요

이 임상시험은 절제 불가능한 국소 진행성 및 전이성 췌장암 환자 88명을 대상으로 합니다. Relafen-α(Retlirafusp alfa), famitinib, nab-paclitaxel, gemcitabine 병용 요법의 유효성과 안전성을 평가하는 단일군, 다기관, 공개 2상 임상시험입니다. 주요 유효성 평가변수는 무진행 생존기간(PFS)입니다. 환자들은 질병이 진행되거나 참을 수 없는 독성이 나타날 때까지 치료를 받습니다.

  • 목표 환자 수는 약 88명이며 절제 불가능한 국소 진행성 및 전이성 췌장암 환자를 대상으로 합니다.
  • 주요 유효성 평가변수는 무진행 생존기간(PFS)입니다.
  • 치료 요법은 Relafen-α, famitinib, nab-paclitaxel, gemcitabine의 병용으로 구성됩니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 18세에서 80세 사이의 모든 성별 - 조직학적으로 확진된 췌장 도관 선암종(pancreatic ductal adenocarcinoma) - 영상 검사로 확인된 절제 불가능한 질환 또는 원격 전이 - 미국동부암연구협회(ECOG) 전신 상태 평가 0-1 - 예상 생존기간 12주 이상 - 이전 전신 항암 치료력 없음

제외 기준: - Retlirafusp alfa, famitinib, gemcitabine, 앨부민 결합 파클리탁셀(nab-paclitaxel) 또는 그 부형제에 과민증이 있는 자 - 췌장선세포암, 췌장 신경내분비종양 등 다른 췌장 악성종양이 조직학적으로 확진된 자 - 임상 증상이 있는 중등도 이상의 흉수, 심낭수, 복수가 있는 자 - 장기 이식 병력이 있는 자 - 이전 전신 항암 치료를 받은 자

선정/제외 기준 원문 (영어)

Inclusion Criteria:

  1. Aged between 18 and 80 years, of any gender;
  2. Histopathologically-confirmed diagnosis of pancreatic ductal adenocarcinoma;
  3. Unresectable disease or distant metastasis confirmed by imaging evidence. Unresectable pancreatic ductal adenocarcinoma is defined as patients with distant metastasis, or a subset of locally advanced pancreatic cancer (LAPC) with invasion of surrounding major blood vessels that cannot be resected and reconstructed;
  4. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
  5. Expected survival ≥ 12 weeks;
  6. No prior systemic anti-cancer treatment;
  7. Adequate function of major organs;
  8. Baseline hematology and blood biochemistry shall meet the following criteria:

White blood cell count ≥ 3.0 × 10⁹/L; hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN; serum creatinine ≤ 1.5 × ULN; albumin ≥ 30 g/L; 9. Females of child-bearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, condoms) throughout the study and for 6 months after study completion, have a negative serum or urine pregnancy test within 7 days prior to enrollment, and shall not be breastfeeding. Male subjects must agree to use effective contraception throughout the study and for 6 months after the end of study treatment; 10. Subjects voluntarily participate in this study, provide written informed consent, have good compliance, and are willing to complete follow-up assessments.

Exclusion Criteria:

  1. Subjects with hypersensitivity to Retlirafusp alfa, famitinib, gemcitabine, albumin-bound paclitaxel or their excipients;
  2. Histopathologically-confirmed other pancreatic malignancies, such as pancreatic acinar cell carcinoma, pancreatic neuroendocrine tumor;
  3. Moderate-to-large pleural effusion, pericardial effusion or ascites with clinical symptoms, which requires frequent drainage (≥ 1 time per week) as judged by the investigator;
  4. History of organ transplantation (including autologous bone-marrow transplantation and peripheral stem-cell transplantation);
  5. Prior receipt of systemic anti-cancer therapy;
  6. Active or uncontrolled severe infection (≥ Grade 2 infection according to CTCAE 5.0), including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia; unexplained fever > 38.5 °C before the first dose;
  7. Subjects with a history of psychoactive substance abuse that cannot be discontinued, or with psychiatric disorders;
  8. History of or concurrent other malignant tumors requiring active treatment within the past 5 years (except for fully-treated basal-cell or squamous-cell skin cancer, carcinoma in situ of the cervix and carcinoma in situ of the breast with an expected 5-year survival rate > 90 %);
  9. Presence of uncorrectable coagulation disorders;
  10. Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina or coronary-artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) class ≥ 2 congestive heart failure; ventricular arrhythmias requiring pharmacotherapy (including baseline QTc interval calculated by Fridericia's correction formula (QTcF): ≥ 450 ms for males and ≥ 470 ms for females); left-ventricular ejection fraction (LVEF) \< 50 %;
  11. Subjects with radiologically-confirmed tumor invasion into major blood vessels, or those judged by the investigator to be at high risk of life-threatening massive hemorrhage due to subsequent tumor invasion of major blood vessels during the study;
  12. Subjects with active autoimmune disease, immunodeficiency, or a medical history including, but not limited to, autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis are excluded. Exceptions: subjects with a history of autoimmune hypothyroidism receiving thyroid-hormone replacement therapy are eligible. Subjects with type 1 diabetes mellitus whose blood-glucose level is well-controlled with insulin regimens may be enrolled;
  13. Subjects receiving immunosuppressants or systemic corticosteroids for immunosuppressive purposes (> 10 mg/day prednisone or equivalent dose of other glucocorticoids) and continuing such treatment within 2 weeks before enrollment;
  14. Arterial or venous thromboembolic events within 3 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral embolism), deep-vein thrombosis and pulmonary embolism;
  15. Gastrointestinal diseases or conditions that, in the investigator's opinion, may affect drug absorption, including but not limited to active gastric/duodenal ulcer, ulcerative colitis, un-resected gastrointestinal tumor with active bleeding, or other conditions at risk of gastrointestinal bleeding or perforation as assessed by the investigator; multiple factors interfering with oral-drug administration (e.g. inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction);
  16. Uncontrolled hypertension despite medication, defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg;
  17. Major surgery (excluding biopsy) performed within 28 days prior to enrollment, or incompletely-healed surgical incision;
  18. Receipt of any other investigational product or participation in another interventional clinical trial within 4 weeks before informed-consent signature;
  19. Pregnant women (positive pregnancy test before drug administration) or breastfeeding women;
  20. Subjects deemed unsuitable for enrollment at the investigator's discretion.

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

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