The American Society of Clinical Oncology Gastrointestinal Cancers Symposium (GI ASCO) recognizes the important role clinical trials play in cancer advancements, especially GI cancers.
We are pleased to share five clinical trials in progress presented at this year’s annual ASCO conference. These are ongoing trials that are currently recruiting cholangiocarcinoma patients.
Please visit our clinical trials section where you can find more ongoing trials.
First-In-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, In Patients with Intrahepatic Cholangiocarcinoma And Other Advanced Solid Tumors. (A Phase I/II Trial Of RLY-4008, A Selective FGFR2 Inhibitor)
A multi-center, global phase I/II trial currently enrolling patients with unresectable or metastatic solid tumors with FGFR2 alterations to be treated with a newly developed highly selective FGFR2 inhibitor. Patients who received prior therapy, including another FGFR2 inhibitor, are eligible for trial enrollment.
ClinicalTrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT04526106
Phase III Study Of NUC-1031 + Cisplatin vs Gemcitabine + Cisplatin for First-Line Treatment Of Patients With Advanced Biliary Tract Cancer (Nutide:121). (A Phase III Trial Of NUC-0131 With Cisplatin)
NUC-1031 is a modified form of gemcitabine designed to overcome gemcitabine resistance mechanisms. The previous phase I trials showed that combined NUC-1031 and cisplatin have an encouraging efficacy and tolerable toxicity. Based on these results, a phase III NuTide:121 trial is currently open for patients’ enrollment. Only patients with no prior therapy are eligible and will be randomized into NUC-1031 + cisplatin versus gemcitabine + cisplatin. NuTide:121 is currently being conducted at approximately 130 sites across North America, Europe, and Asia Pacific countries.
ClinicalTrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT04163900
A Phase II Trial of Trastuzumab Plus Modified-FOLFOX For Gemcitabine/Cisplatin Refractory HER2-Positive Biliary Tract Cancer (BTC): Multi-Institutional Study Of The Korean Cancer Study Group (KCSG-HB19-14). (A Phase II Trial Of Combined Trastuzumab, An Anti-HER2 With FOLFOX)
Trastuzumab, HER2-targeted therapy, has been tested in biliary tract cancer patients. Also, FOLFOX is currently used as second-line chemotherapy after progression on combined gemcitabine and cisplatin. This study evaluates the safety and efficacy of combined trastuzumab and modified-FOLFOX as a second or third-line therapy for Her2- positive biliary tract cancer patients. The trial is done in Asia, and the investigators are currently recruiting patients.
ClinicalTrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT04722133
DNA-Damage Response-Umbrella Study of The Combination Of Ceralasertib And Olaparib, or Ceralasertib And Durvalumab In Advanced Biliary Tract Cancer: A Phase 2 Trial-In-Progress. (A Phase II Trial Of Ceralasertib And Olaparib, Or Durvalumab In BTC)
This trial was designed based on the hypothesis that Ceralasertib, an ATR inhibitor, enhance the anti-tumor effects of durvalumab, an immune checkpoint inhibitor, and Olaparib, a PARP inhibitor. This trial is done in Asia and currently open for patients’ enrollment. They are looking for biliary tract cancer patients who progressed on at least one line of chemotherapy. Patients who received prior PARP or immune checkpoint inhibitors are not eligible for this trial.
A Multi-Center, Randomized Phase 1b/2 Study of Gemcitabine And Cisplatin With or Without CPI-613 As First-Line Therapy For Patients With Advanced Unresectable Biliary Tract Cancer (Bilt-04). (A Phase I/II Trial Of Gemcitabine And Cisplatin +/- CPI-613 For BTC)
This is a combined phase I/II trial to evaluate the dose, safety, and efficacy of adding CPI-613. This drug increases the sensitivity of cancer cells to systemic chemotherapy. If you are interested in getting more information about this trial, please visit
ClinicalTrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT04203160