Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

Sequential Combination of Chemotherapy With Gemcitabine/Oxaliplatin and Photodynamic Therapy in Advanced Cholangiocarcinoma

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00713687

Acronym

GemOx-PDT

Enrollment

Registered

2008-07-11

Start date

2008-08-31

Completion date

2011-12-31

Last updated

2012-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma

Keywords

photodynamic therapy, PDT, gemcitabine, oxaliplatin, cholangiocarcinoma

Brief summary

In patients with cholangiocarcinoma therapeutic effects have been reported for Gemcitabine/Oxaliplatin. Furthermore, photodynamic therapy (PDT) has significantly improved patients survival in two randomised trials. PDT induces tumor necrosis only in an area of few millimetres, while tumor parts which are located beyond this area remain untreated. An additive effect could result from PDT as a local therapy in combination with systemic chemotherapy.

Detailed description

Patients entered in the study receive a sequential therapy consisted of photodynamic therapy followed by systemic chemotherapy (Gemcitabine/Oxaliplatin) 4 weeks later. Systemic chemotherapy every 2 weeks is scheduled 9 times in each cycle. Thereafter, another cycle of PDT followed by chemotherapy is intended.

Interventions

DRUGGemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)

1. Photodynamic therapy (PDT) after successful drainage: Photosan® 2 mg/kg i.v. 48 hrs before laser activation 2. 9 cycles of GemOx chemotherapy (start 4 weeks after PDT): * Gemcitabine 1000 mg/m² 100 min infusion on day 1 of chemotherapy * Oxaliplatin 100 mg/m² 2h infusion on day 2 of chemotherapy * iteration every 14 days * afterwards 4 weeks intermission 3. Iteration of 1. and 2. in case of good compatibility

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Histologic/cytologic verified cholangiocarcinoma or cholangiocarcinoma-typical findings in \>= 2 diagnostic methods * Bile duct stenoses which are technically successful treated with biliary drainage * Irresectability/inoperability * Karnofsky-Index \>= 60% * Age \>= 18 * Written consent Before chemotherapy: * Bilirubin \<= 5 mg/dl * GOT/GPT \< 5x upper standard * Creatinine \< 2x upper standard * Thrombocytes \> 100 G/l * Neutrophils \> 2,00 G/l * Haemoglobin \> 9 g/dl * No occurence of complications during endoscopic procedures (abscess, bilioma, cholecystitis, cholangitis, pancreatitis, biliary leakage)

Exclusion criteria

* Implantation of a metal stent in the bile duct * Previous PDT or chemotherapy * Neoplasia * Porphyria * Pregnant or breastfeeding women * Women of childbearing age and potent men who are not using highly effective contraceptives

Design outcomes

Primary

Measure	Time frame
Progression free survival 6 months after study start	6 months after study start

Secondary

Measure	Time frame
Progression free survival 12 months after study start Progression free interval Overall survival Life quality	Until 12 months after study start

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026