A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Ch… (NCT01900158) | Clinical Trial Compass
CompletedPhase 1
A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas
France, Germany24 participantsStarted 2013-05
Plain-language summary
This is a Phase I Dose Escalation Study in which the safety, tolerability and efficacy of Amphinex®--induced Photochemical Internalisation (PCI) of Gemcitabine followed by Gemcitabine/Cisplatin Chemotherapy will be assessed in patients with advanced inoperable cholangiocarcinomas.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histopathologically/cytologically (C5) verified adenocarcinoma consistent with cholangiocarcinoma
✓. Cholangiocarcinoma that:
✓. 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).
✓. Age ≥ 18 years.
✓. Performance status ECOG ≤ 1.
✓. Estimated life expectancy of at least 12 weeks.
✓. Written informed consent.
Exclusion criteria
✕. Any prior anti-cancer (either local or systemic) treatment for cholangiocarcinoma.
✕. Patients with extra-hepatic metastatic cholangiocarcinoma.
✕. Patients with a severe visceral disease other than cholangiocarcinoma.
✕. Patients with primary sclerosing cholangitis.
✕. Patients with porphyria or hypersensibility to porphyrins.
✕. 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 disease-free interval of \< 5 years before registration/randomization.
What they're measuring
1
Dose-limiting toxicities (DLT) and the safety profile
Timeframe: up to 6 months
2
Schedule-limiting toxicities (SLTs) and the safety profile