EUCTR2012-002888-10-AT
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- PCI Biotech AS
- Enrollment
- 68
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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