Other clinical trials
Not yet recruiting
August 2014 - September 2017Study type: Interventional
Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and gemcitabine chemotherapy. The purpose of this study is to evaluate the effectiveness and safety of the combination of nab-paclitaxel and gemcitabine. The effectiveness will be determined by improvement in the length of time during and after treatment, that the CCA does not get worse. Sponsor: PrECOG, LLC.
Phase 1/Phase 2
June 2014 - December 2016Study type: Interventional
This study considers the safety and tolerability of increasing doses of CX-4945 in combination with gemcitabine plus cisplatin to determine the maximum tolerated dose (MTD), followed by a randomized study that compares antitumor activity in cholangiocarcinoma patients receiving the standard of care gemcitabine plus cisplatin versus CX-4945 at the combination MTD with gemcitabine plus cisplatin. Sponsor: Senhwa Biosciences, Inc.
April 2014 - April 2022Study type: Interventional
This is a multicentre, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. observation alone in patients after curative intent resection of cholangiocarcinoma and muscle invasive gall bladder carcinoma. Sponsor: Universitätsklinikum Hamburg-Eppendorf
March 2014 - March 2016Study type: Interventional
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced solid tumors, including glioma, that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where three cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Sponsor: Agios Pharmaceuticals, Inc.
March 2014 - December 2016Study type: Interventional
The study is a multicenter randomized (1:1) placebo-controlled, double-blinded phase II trial aiming to demonstrate an improvement of median PFS when treating locally advanced unresectable or metastatic patients suffering from an intra-hepatic or hilum (mass-forming) cholangiocarcinoma with Regorafenib as compared to placebo, and after progression after GEM-CDDP (or GEM-OX), or gemcitabine alone followed or preceded by platinum (CDDP or oxaliplatin)-based chemotherapy. The principal objective is to investigate Regorafenib efficacy by prospectively evaluating the PFS after the administration of Regorafenib combined with BSC as compared to placebo with BSC. Hypothesis is a 50% improvement in median PFS (from 6 weeks to 12 weeks in Regorafenib group). Sponsor: Erasme University Hospital
October 2013 - March 2016Study type: Interventional
Stenting the biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice in patients without surgical indications of malignant biliary obstruction.An unicentral clinical trial has demonstrated the safety and technical feasibility of an irradiation biliary stent insertion in patients with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending survival when compared to a conventional biliary stent.However,the small sample size,the population distribution of two groups will influence the final results in obtaining a powerful statistical conclusion.Therefore,a multicentric study was designed to prospectively compared the responses to the treatment with this irradiation biliary stent versus the conventional biliary self-expandable stent in patients with inoperable biliary obstruction caused by cholangiocarcinoma. Sponsor: Zhongda Hospital
September 2013 - April 2018Study type: Interventional
The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma. Sponsor: Center Eugene Marquis
Active, not recruiting
August 2013 - December 2014Study type: Interventional
This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as second-line treatment for cholangiocarcinoma. Sponsor: Sun Yat-sen University
July 2013 - August 2014Study type: Observational [P
Cholangiocarcinoma is a rare and very aggressive neoplasm that arises from the biliary epithelium, constitutes approximately 2% of all reported cancer, and accounts for about 3% of all gastrointestinal malignancies. Up to date, there are many modalities to diagnosis and treat with a range of sensitivity and specificity, and also the advantage and disadvantage of its modality. As physicians, we should be able to assess and choose promptly which modality is best for our patient, even for palliative care. Treatment modalities are surgery and non-surgery like adjuvant chemotherapy, radiation, chemoradiation, radiotherapy, TACE, intra-arterial chemoinfusion, photodynamic therapy, liver transplantation, and palliative therapy. The choice of treatment varies individually. Cholangiocarcinoma has a poor prognosis. Surgical resection offers the only curative option and usually requires a major hepatic resection in addition to resection of the cholangiocarcinoma. Unfortunately, curative resection is possible in only about 30% of patients due to locally advanced disease, distant metastases or comorbidity in elderly patients. Even after resection, the recurrence rate is approximately 60%, resulting in a low 5-year overall survival (OS). Patients with intra-hepatic Cholangiocarcinoma (ICC) have a very limited benefit from systemic chemotherapy, indeed, in unresectable cholangiocarcinoma Overall Survival with systemic chemotherapy is less than 1 year. Since most cholangiocarcinoma patients develop distant metastases at late stages only, locoregional therapy is an interesting therapeutic strategy. Locoregional therapy studies in patients with intrahepatic cholangiocarcinoma employing radiofrequency ablation (RFA), transarterial chemoembolization (TACE) or external as well as internal radiation therapy yielded promising results in the last couple of years. Locoregional therapies have been shown to be effective in patients with ICC. Trans arterial chemoembolization (TACE),for example, is safe in patients with normal liver function, and results in a prolongation of progression free survival (PFS) and OS. Local tumour control may prolong OS and can be achieved by locoregional interventions applied either sequentially or in combination with systemic chemotherapies. TACE is also used as postoperative adjuvant therapy for cholangiocarcinoma, resulting in prolonged survival in patients with tumour size = 5 cm or advanced primary tumor, regional nodes, metastasis (TNM) stage. TACE offers also greater survival benefits than supportive treatment for the palliative treatment of unresectable ICC. TACE is safe and may be effective for prolonging the survival of patients with nonresectable combined hepatocellular carcinoma (HCC) -cholangiocarcinoma, as compared with the historically reported survivals of these patients. Tumor vascularity is highly associated with tumor response. The patient survival period after TACE for combined HCC-cholangiocarcinoma is significantly dependent on tumor size, tumor vascularity, Child-Pugh class, and presence or absence of portal vein invasion. Currently, few centers perform TACE therapy for unresectable Cholangiocarcinoma. Several European studies have reported the efficacy and safety TACE for ICC. The establishment of a registry to obtain the majority of Cholangiocarcinoma cases treated with locoregional approach within and outside Europe can help the investigators evaluate a larger and non-ambiguous sample population. This would help the investigators evaluate the technical success rates, clinical success rates, feasibility and safety of TACE for ICC. All hospitals of IGEVO operating on patients with cholangiocarcinoma are eligible to take part in the Registry. Sponsor: International Group of Endovascular Oncology
Phase 2/Phase 3
June 2013 - June 2016Study type: Observational
This research is a prospective randomized controlled trial.It aimed to determine longterm outcomes and factors associated with increased survival after photodynamic therapy (PDT) through T-tube compared with biliary drainage alone in patients presenting with unresectable bile duct cancer. Sponsor: Central South University
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