EUCTR2012-002888-10-NO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
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 advanced inoperable cholangiocarcinoma (hilar and extrahilar biliary duct region).
- •2. 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).
- •3. Age = 18 years.
- •4. Performance status ECOG = 2
- •5. Estimated life expectancy of at least 12 weeks.
- •6. 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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •1. Any prior anti-cancer (either local or systemic) treatment for cholangiocarcinoma.
- •2. Patients with a severe visceral disease other than cholangiocarcinoma.
- •3. Patients with primary sclerosing cholangitis.
- •4. Patients with porphyria or hypersensibility to porphyrins.
- •5. Concomitant or prior malignant disease, 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.
- •6. Inability to undergo CT or MRI.
- •7. Current participation in any other interventional clinical trial.
- •8. 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.
- •9. Breast feeding women or women with a positive pregnancy test at baseline.
- •10. Inadequate bone marrow function:
- •absolute Neutrophil Count (ANC): <1.5 x 10^9/L, or platelet count <100 x 10^9/L or haemoglobin <6 mmol/L (transfusion allowed).
- •11. Inadequate liver function, defined as:
- •Serum (total) bilirubin >1.5 x the Upper Limit of Normal (ULN) for the institution.
- •Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) >3.0 x ULN (>5 x ULN if liver metastases are present)
- •Alkaline phosphatase levels >5.0 x ULN.
- •12. Inadequate renal function, defined as:
- •Creatinine clearance <60ml/min
- •13. Planned surgery, endoscopic examination or dental treatment in the first 30 days after PCI treatment.
- •14. Co-existing ophthalmic disease likely to require slit-lamp examination within the first 90 days after PCI treatment.
- •15. Clinically significant and uncontrolled cardiac disease including unstable angina, acute myocardial infarction within six 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.
- •16. Known allergy or sensitivity to photosensitisers.
- •17. Ataxia telangiectasia.
- •18. 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.
- •19. Significant hearing impairment.
- •20. Patients concurrently receiving phenytoin.
研究者
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