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진행성 전이성 췌장암 1차 치료에서 surufatinib, camrelizumab 및 AS 병용 요법에 대한 임상시험

Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic 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 NCT05218889
상태 모집 중
단계 1상/2상
시험 약물/중재 surufatinib + camrelizumab + nab-paclitaxel + S-1, nab-paclitaxel + gemcitabine
대상 질환 Pancreatic Cancer, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreas Cancer, Pancreatic Neoplasms
스폰서 Chinese PLA General Hospital
연령·성별 18 Years ~ 75 Years · ALL
목표 인원 90
시작 / 1차 완료 예정 2021-08-04 / 2024-12-16
국내 실시기관 없음
실시 국가 1개국, 기관 1곳 (China)
결과 게시 아니오
최근 갱신 2024-12-31

시험 개요

이 연구는 절제 불가능한 진행성 또는 전이성 췌장암(pancreatic cancer) 환자를 대상으로 surufatinib, camrelizumab, AS(nab-paclitaxel 및 S-1) 병용 요법의 유효성과 안전성을 AG(nab-paclitaxel 및 gemcitabine) 요법과 비교하여 평가하기 위한 임상시험입니다. 1b상 및 2상(phase 1b/2) 단계로 진행되며, 총 90명의 환자를 대상으로 합니다. 현재 중국에서 환자를 모집 중입니다.

  • 절제 불가능한 진행성 또는 전이성 췌장암 환자 90명을 목표로 하는 1b/2상 임상시험입니다.
  • 시험 치료군은 surufatinib, camrelizumab, nab-paclitaxel 및 S-1을 병용합니다.
  • 대조군은 AG(nab-paclitaxel 및 gemcitabine) 요법을 사용합니다.
  • 초록에 명시되지 않음(생존기간, 반응률, 위험비 결과는 아직 초록에 명시되지 않음).

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: 1. 연구에 대해 완전히 이해하고 자발적으로 동의서에 서명한 환자. 2. 조직학적 또는 세포학적으로 확인된 절제 불가능한 국소 진행성 또는 전이성 췌장관선암(pancreatic ductal adenocarcinoma) 환자. 3. 18세에서 75세 사이의 연령. 4. 진행성 췌장암에 대한 이전 전신 치료력이 없는 환자. 5. ECOG PS 0-1. 6. RECIST v1.1 기준에 따라 나선형 CT에서 최장 직경이 10mm 이상, 또는 일반 CT에서 20mm 이상인 측정 가능한 병변이 최소 1개 이상 있는 환자. 7. 예상 생존 기간이 3개월 이상인 환자.

제외 기준: 1. 연구 프로토콜이나 절차를 준수할 수 없는 환자. 2. 이전에 VEGFR 억제제 또는 면역관문억제제(ICI) 치료를 받은 적이 있는 환자. 3. 등록 전 4주 이내에 다른 약물 임상시험에 참여했거나 참여 중인 환자. 4. 등록 전 14일 이내에 수혈, 혈액 제제, 조혈인자를 투여받은 환자. 5. 등록 전 60일 이내에 근접치료(방사성 동위원소 삽입술)를 받은 환자. 6. 등록 전 4주 이내에 화학요법, 신호전달 억제제, 호르몬 요법, 면역요법 등 다른 전신 항종양 치료를 받은 환자. 7. 등록 전 4주 이내에 수술이나 침습적 치료를 받은 환자. 8. 등록 전 60일 이내에 대수술을 받았거나 수술 창상이 완전히 아물지 않은 환자. 9. 등록 전 4주 이내에 간동맥 색전술이나 고주파 절제술 등의 국소 항종양 치료를 받은 환자. 10. 약물로 조절되지 않는 고혈압이 있는 환자.

선정/제외 기준 원문 (영어)

Inclusion Criteria:

  1. Have fully understood this study and voluntarily signed the informed consent form;
  2. Patients with histologically or cytologically confirmed unresectable, locally advanced, or metastatic pancreatic ductal adenocarcinoma;
  3. Age 18-75 years old (inclusive);
  4. No prior systemic therapy for advanced pancreatic carcinoma;
  5. ECOG PS 0-1;
  6. Must have at least one measurable lesion, with the longest diameter of at least 10 mm as measured by spiral CT scan, or at least 20 mm as measured by conventional CT scan (according to Response Evaluation Criteria in Solid Tumors, i.e. RECIST v1.1);
  7. Expected survival ≥ 3 months;
  8. The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors within *14 days before enrollment is not allowed):

Absolute neutrophil count ≥1.5×109/L; Platelets ≥100×109/L; Haemoglobin ≥90 g/L; Total bilirubin \< 1.5 × ULN; ALT and/or AST \< 1.5 × ULN ( \< 3 × ULN for patients with metastases to liver); Serum creatinine \< 1.5 × ULN; Endogenous creatinine clearance ≥50 mL/min; 9. Women of childbearing potential must use effective contraceptive measures; 10. Good compliance and cooperative with follow-up.

Exclusion Criteria:

  1. Unable to comply with the study protocol or study procedures;
  2. Previously received treatment with VEGFR inhibitors, or previously used ICI treatment;
  3. Participating in or having participated in other drug clinical trials within 4 weeks prior to enrollment;
  4. Have received transfusion therapy, blood products, and hematopoietic factors, such as albumin and G-CSF, within 14 days prior to enrollment;
  5. Brachytherapy (radioactive seed implantation) within 60 days prior to enrollment;
  6. Have received other systemic anti-tumor treatments within 4 weeks prior to enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy, and immunotherapy;
  7. Have received any surgery or invasive treatment or procedure within 4 weeks prior to enrollment (excluding intravenous catheterization, paracentesis drainage, etc.);
  8. Undergone major surgery within 60 days prior to enrollment or the surgical incision has not completely healed;
  9. Have received local anti-tumor treatments within 4 weeks prior to enrollment, such as hepatic arterial interventional embolism, cryoablation or radiofrequency ablation of metastases to liver;
  10. The patient currently has hypertension uncontrolled by medication, defined as: blood pressure systolic ≥140 mmHg and/or blood pressure diastolic ≥90 mmHg;
  11. Protein urine ≥2+, or 24-hour protein urine amount ≥1.0 g on urinalysis;
  12. Uncontrollable malignant ascites (defined as ascites that cannot be controlled by diuretics or paracentesis as judged by the investigator);
  13. Clinically significant electrolyte abnormalities as judged by the investigator;
  14. Liver metastases accounted for half or more of the total liver volume as determined by the investigator;
  15. Clinically significant cardiovascular disorders, including but not limited to acute myocardial infarction within 6 months prior to enrollment, severe/unstable angina pectoris, or coronary artery bypass surgery; cardiac failure congestive with NYHA classification > Class II; ventricular arrhythmia requiring drug therapy; LVEF (left ventricular ejection fraction) \<50%;
  16. Hemorrhage events of ≥ Grade 3 occurring within 4 weeks prior to enrollment;
  17. Patients who, within 3 months prior to enrollment, have clear evidence or history of haemorrhagic tendency (hemorrhage >30 mL within 3 months, occurrence of haematemesis, melena, haematochezia), haemoptysis (fresh blood >5 mL within 4 weeks), or have experienced thromboembolic events within 12 months (including stroke events and/or transient ischaemic attack);
  18. INR > 1.5 or APTT > 1.5×ULN, or the patient is currently taking anticoagulants;
  19. Currently, the patient has poorly controlled diabetes mellitus (after standard treatment, fasting glucose concentration ≥ CTCAE Grade 2);
  20. The patient currently has any disease or condition that affects drug absorption, or the patient is unable to take surufatinib orally;
  21. Active or uncontrolled severe infection (≥ CTCAE Grade 2 infection);
  22. Known HIV infection;
  23. Known history of clinically significant liver disease, including hepatitis viral [subjects known to be carriers of HBV must be excluded if they have active HBV infection, i.e., HBV DNA positive (>1×104 copies/mL or >2000 IU/mL); known HCV infection with HCV RNA positive (>1×103 copies/mL)], or other hepatitis, hepatic cirrhosis;
  24. The patient currently has CNS metastasis or a history of brain metastasis;
  25. Patients who currently have gastrointestinal diseases such as active gastric and duodenal ulcer, colitis ulcerative, or active hemorrhage in unresected tumor, or other conditions that may cause gastrointestinal hemorrhage or perforation as determined by the investigator;
  26. Unresolved toxicities higher than CTCAE Grade 1 caused by any prior anti-cancer treatments, excluding alopecia and ≤ Grade 2 neurotoxicity caused by oxaliplatin;
  27. Patients with a known or suspected allergy to the investigational product or drugs of the same class;
  28. Pregnant (positive pregnancy test before medication) or breastfeeding women;
  29. Drug abuse, medical, psychological, or social conditions may affect patient enrollment and the evaluation of experimental results;
  30. Having other untreated or concomitant tumors, except cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors. Patients can be enrolled if the tumor has been radically resected and there is no evidence of disease for more than 3 years. Treatment for all other tumors must have been completed at least 3 years prior to enrollment;
  31. Patients considered by the investigator to be inappropriate for enrollment in this study.

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

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