癌研連線CancerLink
已终止 NCT05131776

EUS 引导肿瘤内注射 OncoSil 用于局部晚期胰腺癌

宫颈癌／妇科肿瘤胰腺癌皮肤癌Phase IIIII 期IV 期

在本地人群中，以 EUS 引导肿瘤内注射 P-32 微粒（OncoSil；OncoSil Medical，澳洲）并同时进行化疗，用于局部晚期胰腺癌的结果尚不确定。 本研究旨在评估此干预措施在本地人群中的疗效及安全性。我们假设此干预措施安全，并有助于肿瘤降期。

适应症：Pancreatic Cancer、Endoscopic Ultrasound

入组条件

纳入标准

  • Study participants are ≥ 18 years of age at screening.
  • Histologically or cytologically proven adenocarcinoma of the pancreas.
  • Unresectable locally advanced pancreatic carcinoma. Patients with technically resectable tumours (T1-T3) will also be eligible, if they are deemed unresectable due to medical comorbidities or refusal of surgery.
  • Pancreatic target tumour diameter ≥ 2.0 cm (shortest axis) to ≤ 6.0 cm (longest axis)
  • An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 - 100.
  • Willing and able to complete study procedures within the study timelines.
  • Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN).
  • Adequate liver function: Serum SGOT/AST and serum SGPT/SLT \< 3 times ULN and serum bilirubin \<1.5 times the ULN unless the patient is known to have prior Gilbert's Syndrome.
  • Adequate bone marrow function: white blood cells (WBCs) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, haemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mm3.
  • Life expectancy of at least 3 months at the time of screening as judged by the investigator.
  • Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the study and agrees not to donate sperm or ova, for the duration of the study and 12 months post implantation of the investigational device.
  • Provide signed Informed Consent.
  • Technically feasible - tumour must be within reach of the EUS probe for fine needle Injection.

排除标准

  • More than one primary lesion.
  • Any prior radiotherapy or chemotherapy for pancreatic cancer.
  • Use of other investigational agent at the time of screening, or within 30 days or five half-lives of Screening Visit 1, whichever is longer.
  • History of malignancy, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ.
  • Evidence of tumour invasion into stomach, duodenum or peritoneum
  • In the opinion of the investigator, EUS directed implantation posing undue study participant risk. This includes:
  • Where previous EUS-FNA was considered technically too difficult to perform;
  • Imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;
  • Presence (or significant risk) of varices near to the target tumour.
  • A known allergy or history of hypersensitivity to silicon, Phosphorus or any of the OncoSil™ components.
  • Patients who do not consent to chemotherapy
  • Actively on medication that increase bleeding risk (i.e. aspirin, clopidogrel, warfarin, NOAC).
  • Any other health condition that would preclude participation in the study in the judgment of the investigator.

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。