Chemotherapy + Y-90 for Bile Duct Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Inova Health Care Services
Must not be taking: Immunosuppressants
Disqualifiers: Pregnancy, Autoimmune diseases, Organ transplant, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?The purpose of this research is to see if combining gemcitabine, cisplatin and Durvalumab chemotherapy treatments with a direct tumor therapy called Yittrium-90, will work better together to shrink the tumor and control cancer.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it does mention that recent use of immunosuppressive medication is not allowed within 14 days before starting durvalumab, except for certain exceptions like low-dose steroids. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the chemotherapy and Y-90 treatment for bile duct cancer?
Research shows that combining gemcitabine with a platinum-based drug like cisplatin is a standard treatment for advanced biliary cancers, and nab-paclitaxel has shown promise in treating similar cancers. Additionally, nab-paclitaxel has been effective in treating other cancers, suggesting potential benefits for bile duct cancer.
12345Is the combination of nab-paclitaxel and gemcitabine generally safe for humans?
Nab-paclitaxel, when combined with gemcitabine, has been shown to have a good safety profile with fewer side effects compared to other formulations in treating various cancers, including pancreatic and gastrointestinal cancers.
36789What makes the Chemotherapy + Y-90 treatment for bile duct cancer unique?
This treatment combines chemotherapy drugs with Yttrium-90, a radioactive substance, to target bile duct cancer. The use of Yttrium-90 allows for direct radiation to the tumor, which is different from standard chemotherapy that typically involves only drugs like gemcitabine and cisplatin.
410111213Eligibility Criteria
This trial is for adults with intrahepatic cholangiocarcinoma (a type of bile duct cancer) that can't be removed by surgery. Participants must be at least 18, have a tumor at least 2 cm big, no cirrhosis or severe liver issues, and an ECOG score of 0-1 indicating they are fully active or restricted in physically strenuous activity but ambulatory. They should not have had previous chemotherapy for this cancer except certain adjuvant therapy.Inclusion Criteria
My bile duct cancer is confirmed and either untreated or was last treated over 6 months ago.
My liver is healthy and I don't have cirrhosis.
My cancer cannot be surgically removed without risking liver function.
+7 more
Exclusion Criteria
Over 75% of my liver is affected by cancer.
My tests show I can't safely receive certain liver cancer treatments due to risks found in my blood vessels.
Anticipated poor compliance
+17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Induction Chemotherapy
Participants receive induction chemotherapy with Gemcitabine, Cisplatin, and Durvalumab
6 months
Radioembolization Treatment
Participants receive Gemcitabine, Cisplatin in combination with Yttrium-90 (Y-90) Radioembolization
6 months
Follow-up
Participants are monitored for safety, effectiveness, and quality of life after treatment
48 months
Participant Groups
The study tests if combining gemcitabine, cisplatin and nab-paclitaxel (chemotherapy drugs) with Yittrium-90 (Y-90), a direct tumor therapy, is more effective in shrinking tumors and controlling cancer than previous treatments. It involves initial 'induction' chemotherapy followed by Y-90 treatment then 'consolidation' therapy.
1Treatment groups
Experimental Treatment
Group I: gemcitabine, cisplatin and Durvalumab chemotherapy with Yittrium-90Experimental Treatment3 Interventions
single arm - Induction Gemcitabine, Cisplatin and Durvalumab Triplet Chemotherapy followed by Gemcitabine, Cisplatin in combination with yttrium-90 (Y-90) Radioembolization
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
🇺🇸 Approved in United States as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
🇨🇦 Approved in Canada as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
🇯🇵 Approved in Japan as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Inova Schar Cancer InstituteFairfax, VA
Keary JanetFairfax, VA
Loading ...
Who Is Running the Clinical Trial?
Inova Health Care ServicesLead Sponsor
References
A Phase II Study of Nab-Paclitaxel and Gemcitabine as First-Line Therapy in Patients with Cholangiocarcinoma Ineligible for Cisplatin-Based Chemotherapy (NACHO). [2023]Gemcitabine and cisplatin is the standard first-line systemic treatment in patients with advanced cholangiocarcinoma (CCA). However, a substantial number of patients do not qualify for cisplatin due to comorbidities or poor performance status. The phase II pilot study NACHO evaluated the efficacy of nab-paclitaxel (125 mg/m2) and gemcitabine (1000 mg/m2) given on days 1, 8, and 15 every 4 weeks as first-line therapy in patients with advanced CCA ineligible for cisplatin-based chemotherapy.
Albumin-bound paclitaxel as new treatment for metastatic cholangiocarcinoma: A case report. [2020]Cholangiocarcinomas are rare and very aggressive tumors. Most patients have advanced-stage or unresectable disease at presentation, and the systemic therapies have limited efficacy. Albumin-bound paclitaxel (nab-paclitaxel) is a solvent-free taxane that has been approved for the treatment of some cancers such as breast, non-small cell lung and pancreatic cancer, however it has not been applied to treat cholangiocarcinoma. We have both preclinical and clinical evidence of the efficacy of nab-paclitaxel in cholangiocarcinoma, yet no phase 3 trials have been made.
Durable response for ampullary and duodenal adenocarcinoma with a nab-paclitaxel plus gemcitabine ± cisplatin combination. [2022]There is no standard salvage chemotherapy for metastatic periampullary adenocarcinoma and duodenal adenocarcinoma and the prognosis of those who fail oxaliplatin, irinotecan, and 5FU is dismal. We examined nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as salvage therapy for these two malignancies.
Gemcitabine and oxaliplatin with or without cetuximab in advanced biliary-tract cancer (BINGO): a randomised, open-label, non-comparative phase 2 trial. [2022]Gemcitabine plus a platinum-based agent (eg, cisplatin or oxaliplatin) is the standard of care for advanced biliary cancers. We investigated the addition of cetuximab to chemotherapy in patients with advanced biliary cancers.
A Single-Arm Phase II Study of Nab-Paclitaxel Plus Gemcitabine and Cisplatin for Locally Advanced or Metastatic Biliary Tract Cancer. [2023]Patients with advanced biliary tract cancer (BTC) have a poor survival. We aim to evaluate the efficacy and safety of nab-paclitaxel plus gemcitabine and cisplatin regimen in Chinese advanced BTC patients.
A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer. [2022]The efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-PTX) plus gemcitabine (GEM) in elderly Japanese patients with pancreatic cancer remain unclear. Therefore, we prospectively investigated the tolerability and efficacy of nab-PTX + GEM in Japanese patients aged ≥ 75 years with non-curatively resectable pancreatic cancer.
Nab-Paclitaxel in the Treatment of Gastrointestinal Cancers-Improvements in Clinical Efficacy and Safety. [2023]Taxanes (paclitaxel and docetaxel) are one of the most useful classes of anticancer drugs. Taxanes are highly hydrophobic; therefore, these drugs must be dissolved in organic solvents (polysorbate or Cremophor EL), which contribute to their toxicities. To reduce this toxicity and to enhance their efficacy, novel formulations have been developed. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is an albumin-stabilized, Cremophor-free, and water-soluble nanoparticle formulation of paclitaxel. Nab-paclitaxel has better solubility and less infusion-associated toxicity compared to solvent-based paclitaxel. Additionally, nab-paclitaxel can be given at higher doses and concentrations compared with solvent-based paclitaxel. Based on its superior clinical efficacy and safety profile, nab-paclitaxel received FDA approval for metastatic breast cancer (2008) and NSCLC (2011). Among gastrointestinal cancers, it is now approved in the USA for treating patients with metastatic adenocarcinoma of the pancreas as first-line therapy in combination with gemcitabine. Furthermore, several clinical trials have suggested the potential efficacy of nab-paclitaxel as a single agent or in combination with other agents for the treatment of metastatic esophageal, gastric, bowel, and biliary tract cancers. Nab-paclitaxel has been demonstrated to have greater overall response rates (ORR) with enhanced progression-free survival (PFS), overall survival (OS) and a superior safety profile with fewer adverse effects in patients with gastrointestinal tract cancers. This review summarizes the advantages associated with nab-paclitaxel-based regimens in terms of improving clinical efficacy and the safety profile in upper gastrointestinal cancer.
Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. [2022]In a phase 1-2 trial of albumin-bound paclitaxel (nab-paclitaxel) plus gemcitabine, substantial clinical activity was noted in patients with advanced pancreatic cancer. We conducted a phase 3 study of the efficacy and safety of the combination versus gemcitabine monotherapy in patients with metastatic pancreatic cancer.
Weekly albumin-bound paclitaxel/cisplatin versus gemcitabine/cisplatin as first-line therapy for patients with advanced non-small-cell lung cancer: A phase II open-label clinical study. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">The aim of this trial was to compare both the efficacy and the safety of a weekly nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus cisplatin vs. gemcitabine plus cisplatin in patients with advanced non-small-cell lung cancer (NSCLC).
PICCA study: panitumumab in combination with cisplatin/gemcitabine chemotherapy in KRAS wild-type patients with biliary cancer-a randomised biomarker-driven clinical phase II AIO study. [2022]Combination chemotherapy has shown benefit in the treatment of biliary cancer and further improvements might be achieved by the addition of a biological agent. We report here the effect of chemotherapy with the monoclonal EGFR antibody panitumumab as therapy for KRAS wild-type biliary cancer.
Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study. [2023]To evaluate the efficacy and safety of tucatinib and trastuzumab in patients with previously treated human epidermal growth factor receptor 2-positive (HER2+) metastatic biliary tract cancer (mBTC).
Phase II marker-driven trial of panitumumab and chemotherapy in KRAS wild-type biliary tract cancer. [2023]Combination chemotherapy has proven beneficial in biliary tract cancer and further improvements may be achieved by individualizing treatment based on biomarkers and by adding biological agents. We report the effect of chemotherapy with panitumumab as first-line therapy for KRAS wild-type irresectable biliary tract cancer.
Use, response and outcomes of second-line chemotherapy in patients with advanced biliary tract cancers. [2023]First-line chemotherapy for advanced biliary tract cancers has been established as gemcitabine and cisplatin; however, there is currently no recognized standard second-line chemotherapy. The purpose of this study is to review and evaluate the outcomes of second-line chemotherapy for advanced biliary tract cancers.