EUCTR2012-002888-10-DE进行中（未招募）1 期
A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability and Efficacy of Amphinex®-induced Photochemical Internalisation (PCI) of Gemcitabine Followed by Gemcitabine/Cisplatin Chemotherapy in Patients with Advanced Inoperable Cholangiocarcinomas
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histopathologically/cytologically (C5) verified adenocarcinoma
- •consistent with cholangiocarcinoma.
- •2. Cholangiocarcinoma that:
- •A) Is considered to be inoperable
- •B) Has a primary lesion in the perihilar biliary duct region that requires
- •stent placement
- •C) Has nodal enlargement =to N1 as per computed
- •tomography/magnetic resonance imaging assessment
- •D) If has metastatic disease, this should be confined to the liver
- •parenchyma only
- •3. Adequate biliary drainage (either at least 50% of the liver volume, or
- •at least two sectors), with no evidence of active uncontrolled infection
- •(patients on antibiotics are eligible)
- •4. Age =18 years
- •5. The Eastern Cooperative Oncology Group performance status =1
- •6. Estimated life expectancy of at least 12 weeks
- •7. Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Any prior anti-cancer (either local or systemic) treatment for
- •cholangiocarcinoma
- •2. Patients with extra-hepatic metastatic cholangiocarcinoma
- •3. Patients with a severe visceral disease other than
- •cholangiocarcinoma.
- •4. Patients with primary sclerosing cholangitis
- •5. Patients with porphyria or hypersensibility to porphyrins
- •6. Patients with an active second primary cancer, with exception of
- •adequately treated basal cell carcinoma, squamous cell carcinoma or
- •other non-melanomatous skin cancer, or in-situ carcinoma of the uterine
- •cervix. An active second primary cancer is defined as one with a diseasefree
- •interval of <5 years before registration/randomisation.
- •7. Inability to undergo computed tomography or magnetic resonance
- •8. Current participation in any other interventional clinical trial
- •9. Male patients not willing to use adequate contraception or female
- •patients of childbearing potential not willing to use an effective form of
- •contraception such as hormonal birth control, intrauterine device or
- •double barrier method during PCI treatment and subsequent
- •chemotherapy and for at least 6 months thereafter.
- •10. Breast feeding women or women with a positive pregnancy test at
- •11. Inadequate bone marrow function:
- •- Absolute neutrophil count: <1.5 x 109/L, or platelet count <100 x
- •109/L or haemoglobin <6 mmol/L (transfusion allowed)
- •12. Inadequate liver function, defined as:
- •- Serum (total) bilirubin >2.5 x the upper limit of normal for the
- •institution
- •- Aspartate amino transferase or alanine amino transferase >3.0 x upper limit of normal (>5.0 x upper limit of normal if liver metastases are
- •- Alkaline phosphatase levels >5.0 x upper limit of normal
- •13. Inadequate renal function, defined as:
- •- Creatinine clearance <60 mL/min
- •14. Planned surgery, endoscopic examination or dental treatment in the
- •first 30 days after PCI treatment
- •15. Co-existing ophthalmic disease likely to require slit-lamp
- •examination within the first 90 days after PCI treatment
- •16. Clinically significant and uncontrolled cardiac disease including
- •unstable angina, acute myocardial infarction within 6 months prior to
- •baseline, congestive heart failure, and arrhythmia requiring therapy,
- •with the exception of extra systoles or minor conduction abnormalities
- •and controlled and well treated chronic atrial fibrillation
- •17. Known allergy or sensitivity to photosensitisers
- •18. Ataxia telangiectasia
- •19. Evidence of any other medical conditions (such as psychiatric illness,
- •infectious diseases, physical examination or laboratory findings) that
- •may interfere with the planned PCI treatment, affect patient compliance
- •or place the patient at high risk from treatment-related complications
- •20. Significant hearing impairment
- •21. Patients concurrently receiving phenytoin
- •22. Patients defined as vulnerable according to French law (France only,
- •also see Section 5.4
研究者
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