研究调查全身化疗加ponsegromab与全身化疗加安慰剂用于一线治疗恶病质和转移性胰腺导管腺皮瘤的成年参与者的有效性、安全性和耐受性。
适应症：Cachexia、Metastatic Pancreatic Ductal Adenocarcinoma
入组条件
纳入标准
- Signed Informed Consent Document
- Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma
- Cachexia defined by Fearon criteria of weight loss
- Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy
- ECOG PS ≤1 with life expectancy of at least 4 months
排除标准
- Current active reversible causes of decreased food intake
- Cachexia caused by other reasons
- Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification
- Left ventricular ejection fraction \<50%
- Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
- History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients
- Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases
- Inadequate liver function
- Renal disease requiring dialysis or eGFR \<30 mL/min/1.73m2
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。