NCT01267344: BTC

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

Completed Phase 2 Last updated 3 May 2016

What this trial tests

Phase 2 trial testing gemcitabine, oxaliplatin in Cholangiocarcinoma in 122 participants. Completed in 1 May 2015.

Timeline

1 December 2010

Primary endpoint
1 December 2013

1 May 2015

Quick facts

Lead sponsor	National Health Research Institutes, Taiwan
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	122
Start date	1 December 2010
Primary completion	1 December 2013
Estimated completion	1 May 2015
Sites	1 location across Taiwan

Drugs / interventions tested

• gemcitabine, oxaliplatin
• cetuximab, gemcitabine, oxaliplatin

Conditions studied

• Cholangiocarcinoma — all drugs for Cholangiocarcinoma →
• Adenocarcinoma of Gallbladder — all drugs for Adenocarcinoma of Gallbladder →

Sponsor

National Health Research Institutes, Taiwan

Who can join

20 and older, any sex, with Cholangiocarcinoma or Adenocarcinoma of Gallbladder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• objective response rate
  Time frame: baseline and every 8 weeks
  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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging strategies to target RAS signaling in human cancer therapy.
   Chen K, Zhang Y, Qian L, Wang P. · · 2021 · cited 164× · PMID 34301278 · DOI 10.1186/s13045-021-01127-w
2. A KRAS mutation status-stratified randomized phase II trial of gemcitabine and oxaliplatin alone or in combination with cetuximab in advanced biliary tract cancer.
   Chen JS, Hsu C, Chiang NJ, Tsai CS, et al · · 2015 · cited 120× · PMID 25632066 · DOI 10.1093/annonc/mdv035
3. Trial watch: Chemotherapy with immunogenic cell death inducers.
   Vacchelli E, Galluzzi L, Fridman WH, Galon J, et al · · 2012 · cited 98× · PMID 22720239 · DOI 10.4161/onci.1.2.19026
4. The landscape of targeted therapies for cholangiocarcinoma: current status and emerging targets.
   Chong DQ, Zhu AX. · · 2016 · cited 81× · PMID 27102149 · DOI 10.18632/oncotarget.8775
5. Molecular genetics and targeted therapeutics in biliary tract carcinoma.
   Marks EI, Yee NS. · · 2016 · cited 42× · PMID 26819503 · DOI 10.3748/wjg.v22.i4.1335
6. Genomics of gallbladder cancer: the case for biomarker-driven clinical trial design.
   Sicklick JK, Fanta PT, Shimabukuro K, Kurzrock R. · · 2016 · cited 41× · PMID 26857926 · DOI 10.1007/s10555-016-9602-8
7. Targeted Therapy in Biliary Tract Cancers.
   Merla A, Liu KG, Rajdev L. · · 2015 · cited 25× · PMID 26266637 · DOI 10.1007/s11864-015-0366-0
8. Molecular Targets and Emerging Therapies for Advanced Gallbladder Cancer.
   Canale M, Monti M, Rapposelli IG, Ulivi P, et al · · 2021 · cited 17× · PMID 34830826 · DOI 10.3390/cancers13225671