Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-04 @ 6:04 AM
Study NCT ID:
NCT03086993
Status:
UNKNOWN
Last Update Posted:
2022-03-24
First Post:
2017-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Hepatic Perfusion vs. Cisplatin/Gemcitabine in Patients With Intrahepatic Cholangiocarcinoma
Sponsor:
Delcath Systems Inc.
Organization:
Study Overview
Official Title:
Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine Versus Cisplatin/Gemcitabine in Patients With IntraHepatic Cholangiocarcinoma
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate two groups of patients who have intrahepatic cholangiocarcinoma. Each group will receive induction treatment with Cisplatin and Gemcitabine per SOC for 4 treatment cycles. Following induction treatment patients will be randomize (1:1), to 2 arms of treatment. One group (50%) will be receive high dose chemotherapy delivered specifically to the liver, while the other group (50%) will continue treatment with Cisplatin and Gemcitabine. Patient in each group will get repeating cycles of treatment until the cancer advances. All patients will be followed until death. This study will compare the overall survival (OS) in patients with intrahepatic cholangiocarcinoma.
Detailed Description:
The study will consist of 4 phases: a screening, an induction, randomization and follow-up phase.
Screening phase: Screening assessments will be conducted within 28 days prior to initiation of Induction Phase treatment to determine each patient's overall eligibility. These assessments will include medical history; physical examination; Eastern Cooperative Oncology Group (ECOG) performance status (PS); 12 lead electrocardiogram (ECG); echocardiogram (ECHO); vital signs; laboratory assessments; radiologic assessments of disease status; and an evaluation of the vasculature compatibility for Percutaneous Hepatic Perfusion (PHP).
Induction phase: The initial 12 weeks of the study, all patients will receive 4 cycles of cisplatin/gemcitabine. Each cycle will be comprised of cisplatin dosed at 25 mg per square meter of body-surface area (BSA), followed by gemcitabine dosed at 1000 mg per square meter of BSA; dosing will occur on Days 1 and 8 of each cycle. At the completion of 3 cycles (week 8 (+1 week)) of cisplatin/gemcitabine, an imaging scan is performed as per standard of care to determine if the patient has progressed on treatment or should continue receiving the cisplatin/gemcitabine induction therapy for one more cycle (4th cycle - prior to randomization). At the completion of 4 cycles (week 12 (+1 week)) of cisplatin/gemcitabine, patients will undergo whole-body imaging to determine the status of their disease. Patients with progressive disease (PD) will be discontinued from study treatment, and will receive further treatment to be determined by the principal investigator (PI). They will continue to be followed until death or the end of the study. Patients who have at least stable disease (SD) at imaging after induction phase of 4 cycles of cisplatin/gemcitabine (week 12 (+ 1 week)) will go on to the next phase of the study (Randomized Treatment Phase).
Randomization phase: Patients who have at least stable disease via imaging at the end of the Induction Phase will be randomized in a 1:1 ratio to Melphalan/HDS treatment or to continue cisplatin/gemcitabine in cycles previously described in the Induction Phase, until progressive disease (PD) or unacceptable toxicity is observed. Patients who were randomized to treatment with Melphalan/HDS (dosed at 3.0 mg/kg Ideal Body Weight \[IBW\]) must undergo their first treatment within 14 days following the whole body imaging performed at end of the Induction Phase. For Melphalan/HDS treatment, patients will receive up to 6 treatments. Each treatment cycle will consist of 6 weeks with an acceptable delay for up to another 2 weeks before the next planned treatment to allow for additional recovery, if needed. After the Melphalan/HDS treatment, in the absence of disease progression, the patient should undergo a re-induction of CisGem. Tumor response will be assessed in both treatment arms every 8 weeks (+ 1 week) until PD.
The assessment scans will be reviewed by Independent Review Committee (IRC). At any time when PD is observed, the patient will be removed from further study treatment; any further treatment will be at the discretion of the investigator. Melphalan/HDS treatment will also be discontinued in the event that recovery requires more than 8 weeks from last treatment. An end-of-treatment visit will be conducted approximately 6 to 8 weeks following the final dose of study treatment. Ongoing adverse events (AEs) at the end-of-treatment visit will be followed until the severity returns to common terminology criteria for adverse events (CTCAE) Grade \< 1.
Follow-up phase: In the event that disease has not progressed at the end-of-treatment visit, disease assessment scans will continue every 8 weeks (+ 1 week) until PD is documented. Patients will be contacted by phone every 6 months for survival status for the first two years following the completion of study treatment, then yearly thereafter until death, withdrawal of informed consent or they become lost to follow-up, whichever occurs first. Patients will be monitored for two years following the completion of study treatment for the development of myelodysplasia and secondary leukemia.
Screening phase: Screening assessments will be conducted within 28 days prior to initiation of Induction Phase treatment to determine each patient's overall eligibility. These assessments will include medical history; physical examination; Eastern Cooperative Oncology Group (ECOG) performance status (PS); 12 lead electrocardiogram (ECG); echocardiogram (ECHO); vital signs; laboratory assessments; radiologic assessments of disease status; and an evaluation of the vasculature compatibility for Percutaneous Hepatic Perfusion (PHP).
Induction phase: The initial 12 weeks of the study, all patients will receive 4 cycles of cisplatin/gemcitabine. Each cycle will be comprised of cisplatin dosed at 25 mg per square meter of body-surface area (BSA), followed by gemcitabine dosed at 1000 mg per square meter of BSA; dosing will occur on Days 1 and 8 of each cycle. At the completion of 3 cycles (week 8 (+1 week)) of cisplatin/gemcitabine, an imaging scan is performed as per standard of care to determine if the patient has progressed on treatment or should continue receiving the cisplatin/gemcitabine induction therapy for one more cycle (4th cycle - prior to randomization). At the completion of 4 cycles (week 12 (+1 week)) of cisplatin/gemcitabine, patients will undergo whole-body imaging to determine the status of their disease. Patients with progressive disease (PD) will be discontinued from study treatment, and will receive further treatment to be determined by the principal investigator (PI). They will continue to be followed until death or the end of the study. Patients who have at least stable disease (SD) at imaging after induction phase of 4 cycles of cisplatin/gemcitabine (week 12 (+ 1 week)) will go on to the next phase of the study (Randomized Treatment Phase).
Randomization phase: Patients who have at least stable disease via imaging at the end of the Induction Phase will be randomized in a 1:1 ratio to Melphalan/HDS treatment or to continue cisplatin/gemcitabine in cycles previously described in the Induction Phase, until progressive disease (PD) or unacceptable toxicity is observed. Patients who were randomized to treatment with Melphalan/HDS (dosed at 3.0 mg/kg Ideal Body Weight \[IBW\]) must undergo their first treatment within 14 days following the whole body imaging performed at end of the Induction Phase. For Melphalan/HDS treatment, patients will receive up to 6 treatments. Each treatment cycle will consist of 6 weeks with an acceptable delay for up to another 2 weeks before the next planned treatment to allow for additional recovery, if needed. After the Melphalan/HDS treatment, in the absence of disease progression, the patient should undergo a re-induction of CisGem. Tumor response will be assessed in both treatment arms every 8 weeks (+ 1 week) until PD.
The assessment scans will be reviewed by Independent Review Committee (IRC). At any time when PD is observed, the patient will be removed from further study treatment; any further treatment will be at the discretion of the investigator. Melphalan/HDS treatment will also be discontinued in the event that recovery requires more than 8 weeks from last treatment. An end-of-treatment visit will be conducted approximately 6 to 8 weeks following the final dose of study treatment. Ongoing adverse events (AEs) at the end-of-treatment visit will be followed until the severity returns to common terminology criteria for adverse events (CTCAE) Grade \< 1.
Follow-up phase: In the event that disease has not progressed at the end-of-treatment visit, disease assessment scans will continue every 8 weeks (+ 1 week) until PD is documented. Patients will be contacted by phone every 6 months for survival status for the first two years following the completion of study treatment, then yearly thereafter until death, withdrawal of informed consent or they become lost to follow-up, whichever occurs first. Patients will be monitored for two years following the completion of study treatment for the development of myelodysplasia and secondary leukemia.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: