진행성 췌장암에서 순차적 AG 및 mFOLFOX 병용 요법과 Serplulimab 및 Bevacizumab의 효과를 AG 단독 요법과 비교하는 3상 임상시험

Firstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced 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	NCT07235930
상태	모집 중
단계	3상
시험 약물/중재	Sequential AG and mFOLFOX in Combination With Serplulimab and Bevacizumab, AG chemotherapy
대상 질환	Non-Resectable Pancreas Carcinoma
스폰서	Zhejiang Cancer Hospital
연령·성별	18 Years ~ 75 Years · ALL
목표 인원	292
시작 / 1차 완료 예정	2025-11-15 / 2029-07-01
국내 실시기관	없음
실시 국가	1개국, 기관 1곳 (China)
결과 게시	아니오
최근 갱신	2025-11-19

문의처 (등록된 중앙 연락처)

• Jieer Ying, Doctor 13858195803 jieerying@aliyun.com

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

시험 개요

본 임상시험은 이전에 치료받지 않은 절제 불가능한 국소 진행성 또는 전이성 췌장 췌관 암종 환자 292명을 대상으로 합니다. 순차적 AG(Nab-paclitaxel/Gemcitabine) 및 mFOLFOX 항암화학요법에 Serplulimab과 Bevacizumab을 병용하는 치료법의 유효성과 안전성을 평가합니다. 이를 기존의 AG 단독 항암화학요법과 무작위 배정하여 비교합니다. 1차 평가변수는 전체 생존기간(OS)이며, 주요 2차 평가변수로는 무진행 생존기간(PFS), 객관적 반응률(ORR), 안전성이 포함됩니다.

• 목표 환자 수는 약 292명이며 중국에서 진행됩니다.
• 1차 평가변수는 전체 생존기간(OS)입니다.
• 주요 2차 평가변수는 무진행 생존기간(PFS), 객관적 반응률(ORR), 안전성입니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 연구 참여에 자발적으로 동의하고 동의서를 서란한 18세 이상 75세 이하의 환자 - 병리 조직학 또는 세포학으로 확진된 췌장 췌관 암종 환자 - 절제 불가능한 국소 진행성 또는 전이성 췌장암에 대해 이전에 전신 치료를 받은 적이 없는 환자 - RECIST 1.1 기준에 따른 측정 가능한 병병이 있는 환자 - ECOG 신체 상태 점수가 0 또는 1이며, 기대 여명이 12주 이상인 환자 - 골수, 응고, 간, 신장, 심장 기능이 적절히 유지되는 환자

제외 기준: - 영상 검사에서 명확한 뇌 전이 또는 수막 전이가 있는 환자 - 수술 및/또는 방사선 치료로 치료되지 않은 치료되지 않은 척추 압박 골절 환자 - 위장관 또는 복부 출혈의 위험이 높은 환자 - 조절되지 않는 암성 통증이 있는 환자 - 이전에 혈관내피성장인자(VEGFR) 억제제 또는 면역관문 억제제로 치료받은 적이 있는 환자

선정/제외 기준 원문 (영어)

Inclusion Criteria:

1. Voluntarily agree to participate in the study and sign the informed consent;
2. ≥18 years of age and ≤75 years of age on the day of signing the informed consent form, regardless of gender;
3. Pancreatic ductal adenocarcinoma confirmed by pathologic histology or cytology;
4. No prior systemic therapy for unresectable locally advanced or metastatic pancreatic cancer;
5. Measurable lesions at baseline according to RECIST 1.1 criteria; if the subject has only 1 measurable lesion at baseline, the area of the lesion must not have received radiotherapy in the past or there must be evidence of significant progression of the lesion after completion of radiotherapy treatment;
6. the ECOG physical status score was 0 or 1 and the Expected survival ≥12 weeks;
7. No serious organic diseases of the heart, lungs, brain and other organs;

8. Adequate organ function

9. Bone Marrow Function: (no transfusion within 14 days prior to screening, no use of granulocyte colony stimulating factor [G-CSF], no use of drug correction) : i. Hemoglobin ≥90g/L; ii. Leukocytes ≥ 4.0 x 109/L, Neutrophils ≥1.5×109/L; iii. Platelet ≥80×109/L;

10. Coagulation function: PT or APTT ≤ 1.5 x ULN in subjects not receiving anticoagulation; if subjects are receiving anticoagulation, as long as the PT is within the range of the anticoagulant drug formulation;
11. liver function: (no albumin infusion within 14 days prior to screening): Serum total bilirubin ≤ 1.5 x ULN (with biliary obstruction, allowing enrollment of subjects undergoing biliary drainage or in the midst of stenting therapy who have a total bilirubin ≤ 2.5 x ULN). In subjects without liver metastasis, Aspartate aminotransferase (AST), alanine aminotransferase (ALT)≤2.5×ULN; In subjects with liver metastasis, ALT and AST≤5×ULN, but without elevated bilirubin;
12. Renal function: serum creatinine ≤1.5 x ULN, creatinine clearance (CCr) ≥50 mL/min, urinary protein \<2+ (if urinary protein ≥2+, 24-hour (h) urinary protein quantification can be carried out, and 24h urinary protein quantification \<1.0 g can be enrolled)
13. Heart function: New York College of Cardiology (NYHA) rating \< 3; Left ventricular ejection fraction ≥50%;
14. Male or female patients of childbearing potential will voluntarily use an effective method of contraception, such as a double-barrier contraceptive method, condoms, oral or injectable contraceptives, and an intrauterine device (IUD), for the duration of the study and up to 6 months after the last study dose. All female patients will be considered of childbearing potential unless the female patient is naturally menopausal, artificially menopausal or sterilized;
15. Subject's ability and willingness to comply with visits, treatment plans, laboratory tests, and other study-related processes as specified in the study protocol.

Exclusion Criteria:

1. subjects with clear brain metastases on imaging or with meningeal metastases;
2. untreated spinal compression fractures not treated by surgery and/or radiotherapy; treated spinal compression fractures require disease stabilization for at least 2 weeks prior to enrollment;
3. high risk of gastrointestinal or abdominal bleeding as evaluated by the Investigator;
4. uncontrolled cancer pain; narcotic analgesics not at a stable dose at enrollment;
5. previous treatment with vascular endothelial growth factor (VEGFR) inhibitors or previous treatment with immune checkpoint inhibitors;
6. antitumor treatment with chemotherapy, small molecule inhibitors, immunotherapy (e.g., interleukin, interferon, or thymosin) within 28 days prior to enrollment in this study, and herbal medicine with antitumor indications within 14 days prior to dosing;
7. major surgical procedures [such as transabdominal, transthoracic and other major surgeries; excluding diagnostic puncture such as ultrasonic endoscopy-guided pancreatic fine-needle aspiration biopsy (EUS-FNB), percutaneous hepatic perforation biopsy, peripheral venous catheterization, and biliary stent implantation] or invasive treatments or operations with incomplete healing of the surgical incision, local anti-tumor treatment such as hepatic artery interventional embolization, hepatic metastasis cryo-ablation, radiofrequency ablation and other local anti-tumor treatments. radiofrequency ablation and other local antitumor therapy;
8. have received radical radiotherapy within 3 months prior to study entry; palliative radiotherapy 2 weeks prior to dosing is permitted, and the dose of radiotherapy meets local standards of care for palliative care;
9. required systemic corticosteroid (>10 mg/day prednisone or equivalent of other corticosteroid for ≥7 consecutive days) or immunosuppressive therapy within 14 days prior to enrollment in this study; with the exception of inhaled or locally applied hormones, or physiologic replacement doses of hormone therapy due to adrenal insufficiency; short-term (≤7 days) corticosteroids are allowed for prophylaxis (e.g., contrast allergy) or treatment of Non-autoimmune conditions (eg, delayed hypersensitivity reactions caused by exposure to allergens) ;
10. subjects with uncorrectable albumin decline (serum albumin \<3.0 g/dL) 14 days prior to enrollment in this study; and
11. a 10% or greater weight loss in comparison to the weight loss at the time of ICF signing within 72 hours prior to enrollment in this study; and
12. within 72 hours prior to study entry, the subject's ECOG physical status score increases by ≥1 point compared to the ICF score; 13. within 28 hours prior to study entry, the subject's ECOG physical status score increases by ≥1 point compared to the ICF score; and
13. has received a live vaccine (including live attenuated vaccine) within 28 days prior to enrollment in this study;
14. previous or current interstitial pneumonia/pneumatosis, unless determined by the investigator to be inactive and not requiring hormonal therapy; and
15. pre-existing or current autoimmune disease, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome (granulomatous disease with polyangiitis), Graves' disease, rheumatoid arthritis, hypopituitarism, uveitis, autoimmune hepatitis, systemic sclerosis ( Scleroderma, etc.), Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome). The following conditions are excluded: type I diabetes mellitus, hypothyroidism stabilized by hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo that does not require systemic therapy;
16. a combination of other malignancies within the last 5 years, except cured squamous skin cancer, basal cell carcinoma, non-basal invasive bladder cancer, and prostate/cervical/breast cancer in situ;
17. hepatic metastases comprising more than 50% of the total liver volume;

18. uncontrolled comorbidities, including but not limited to the following

    1. Active HBV or HCV infection; (Note: HBV DNA and/or HCV RNA testing is required for subjects who are HBsAg positive and/or HCV antibody positive at Screening. Subjects who are negative for HBV DNA ≤500 IU/mL (or ≤2000 copies/mL) and/or HCV RNA are eligible for enrollment; HBsAg-positive subjects are required to have their HBV DNA monitored during the course of treatment);
    2. Known history of HIV infection or AIDS;
    3. Active syphilis;
    4. Active tuberculosis;
    5. Active or uncontrolled serious infection (≥ CTCAE grade 2 infection);
    6. Medication-uncontrolled hypertension (defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;), symptomatic cardiac insufficiency (NYHA II-IV), unstable angina pectoris or myocardial infarction within 6 months, or the presence of a prolonged QTc or risk of torsades de pointes (baseline QTc>470 msec (women)/450 msec (men) \< Fridericia method correction>, hypokalemia, long QT syndrome, atrial fibrillation with heart rate >100 bpm at rest or severe cardiac valvular disease, history of medically significant arrhythmias);

19. unrecovered toxicity from prior antitumor therapy to CTCAE ≤ Grade 1 (NCI-CTCAE v5.0), except for baldness (any grade allowed) and peripheral neuropathy (recovery to ≤ Grade 2 required);

20. history of prior allogeneic bone marrow or organ transplantation;
21. prior history of allergic reaction, hypersensitivity reaction, intolerance to investigational drugs or similar medications; prior significant allergy to drugs or foods or other substances (e.g., severe allergic reaction, immune-mediated hepatotoxicity, immune-mediated thrombocytopenia, or anemia)
22. pregnant and/or lactating women;
23. other conditions that, in the opinion of the investigator, would affect the safety of or adherence to treatment with the study medication, including alcoholism, drug abuse, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, the presence of serious laboratory test abnormalities, moderate to large amounts of plasmapheresis such as pleural fluid, pericardial effusion, ascites, and other concomitant familial or social factors, which would affect the safety of the patient;

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

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