Neoplasms

All Conditions

Rare Diseases

Adenocarcinoma

Cholangiocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cetuximab

Oxaliplatin

Antimetabolites

Antineoplastic Agents, Immunological

Intravenous infusion of gemcitabine 800 mg/m2 at a fixed rate of 10 mg/m2/min followed by oxaliplatin 85 mg/m2 2-hour infusion, every 2 weeks.

Arm A will receive E-GEMOX with additional intravenous infusion of cetuximab (120 minutes for the 1st, 90 minutes for the 2nd and 60 minutes for all subsequent infusions) before GEMOX will be administered as above.

GEMOX (intravenous infusion of gemcitabine 800 mg/m2 at a fixed rate of 10 mg/m2/min followed by oxaliplatin 85 mg/m2 2-hour infusion, every 2 weeks

gemcitabine, oxaliplatin

E-GEMOX: intravenous infusion of cetuximab (120 minutes for the 1st, 90 minutes for the 2nd and 60 minutes for all subsequent infusions) before GEMOX will be administered as above. All of the study medication will be administrated on day 1 every 2 weeks, which is regarded as one cycle.

cetuximab, gemcitabine, oxaliplatin

Li Tz Chen, PHD

Tsang Wu Liu, MD

The primary objective is to investigate the objective response rate in patients receiving GEMOX (gemcitabine plus oxaliplatin) plus cetuximab as first line treatment in advanced or metastatic unresectable BTC biliary tract cancer compared to patients receiving the same chemotherapy without cetuximab. The secondary objectives include the exploration of the effect of the multimodality strategy on progression-free and overall survival, biomarker prediction, and toxicity.

It is considered realistic, that within 18 months 120 patients can be included in the participating centers. Based on the previous publications an objective response rate (ORR) of 20% is expected in the GEMOX arm (Arm B). When the sample size of evaluable patients is between 110 and 120 evaluable patients (ie. 55 to 60 patients per treatment arm), then a two-sided 95% confidence interval (CI) for the difference between an arm B response rate PB, of 20% and an arm A response rate PA of 30%, 35% or 40% based on the large sample normal approximation will have a width between 15.4% and 16.7%. We assume an objective response rate of 30% for Arm A, then a two-sided 95% confidence interval (CI) for the difference between an arm B response rate PB, of 20% and an arm A response rate PA of 30% will have a width ±15.4% when the sample size of evaluable patients is 120 (i.e., 60 patients per treatment arm).

A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC

A Randomized Phase II Study of Gemcitabine Plus Oxaliplatin (GEMOX) With or Without Cetuximab in Locally Advanced and Metastatic Biliary Tract Cancer (BTC)

Evaluation of tumor response according to RECIST 1.1 version Evaluation will be done at baseline and every 8 weeks. Evaluation will be performed with CT or MRI.

Treatment toxicity will be graded by NCI Common Toxicity Criteria Version 4.0 (CTC, v4.0) for safety evaluation

National Taiwan University Hospital

Taipei Veterans General Hospital, Taiwan

Mackay Memorial Hospital

Tri-Service General Hospital

Chang Gung Memorial Hospital

Taichung Veterans General Hospital

China Medical University Hospital

National Cheng-Kung University Hospital

Kaohsiung Medical University

Kaohsiung Veterans General Hospital.

National Health Research Institutes, Taiwan

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Sorafenib

Gemcitabine 1,000 mg/m2 infusion for 30minutes and followed by oxaliplatin 100mg/m2 infusion for 2hours on day1. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death.

Gemcitabine, Oxaliplatin

Hye Jin Choi

The purpose of this study is to test the safety of gemcitabine and oxaliplatin regimen and to see its effects on sorafenib treatment failed hepatocellular carcinoma patients.

Patients who progressed after or cannot tolerate sorafenib treatment. Patients who cannot receive sorafenib for other reason are also permitted. Treatment is given in cycles, each cycle is 2 weeks long. Tumor measurements by CT and/or MRI will be repeated every 3 cycles. Patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects.

Gemcitabine With Oxaliplatin (GEMOX) in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment

Phase II Study of Gemcitabine With Oxaliplatin in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.

Overall safety profile verified as relevance of adverse events and laboratory abnormality based on CTCAE v4.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC	NCT01267344	Cholangiocarcin... Adenocarcinoma ...	gemcitabine, ox... cetuximab, gemc...	20 Years -	National Health Research Institutes, Taiwan
A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC	NCT01267344	Cholangiocarcin... Adenocarcinoma ...	gemcitabine, ox... cetuximab, gemc...	20 Years -	National Health Research Institutes, Taiwan
Gemcitabine With Oxaliplatin (GEMOX) in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment	NCT05517239	Hepatocellular ...	Gemcitabine, Ox...	20 Years -	Yonsei University
Gemcitabine With Oxaliplatin (GEMOX) in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment	NCT05517239	Hepatocellular ...	Gemcitabine, Ox...	20 Years -	Yonsei University

Spots Global Cancer Trial Database for gemcitabine, oxaliplatin