Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05342194
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-08-15
First Post:
2022-04-07
Brief Title:
Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC a Phase III Study
Sponsor:
Shanghai Junshi Bioscience Co Ltd
Organization:
Shanghai Junshi Bioscience Co Ltd
Study Overview
Official Title:
A Phase III Randomized Three-arm Double-blind Placebo-controlled International Multi-center Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Lenvatinib and Gemcitabine-based Chemotherapy Compared With Gemcitabine-based Chemotherapy as First-line Treatment in Patients With Unresectable Advanced Intrahepatic Cholangiocarcinoma ICC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase III prospective randomized three-arm double-blind placebo-controlled international multicenter study to evaluate the efficacy and safety of toripalimab in combination with lenvatinib and gemcitabine-based chemotherapy compared with gemcitabine-based chemotherapy as first-line treatment for unresectable advanced ICC
This study will enroll approximately 480 patients with unresectable advanced ICC who have received no prior systemic therapy Patients who meet the requirements will be randomly assigned to Treatment Arm A Toripalimab lenvatinib and gemcitabine-based chemotherapy or Treatment Arm B Toripalimab oral placebo and gemcitabine-based chemotherapy or Treatment Arm C Intravenous placebo oral placebo and gemcitabine-based chemotherapy
All patients will receive standard chemotherapy GEMOX or GC per Investigator decision for a maximum of 8 cycles After the completion of standard chemotherapy all patients continue to receive maintenance therapy with toripalimab injection or its placebo in combination with lenvatinib mesylate capsule or its placebo until unacceptable toxicity confirmed disease progression and loss of clinical benefit as determined by the investigators start of new anti-cancer therapy death other conditions requiring termination of study treatment or the patient meets the criteria for study withdrawal whichever occurs first
In the absence of unacceptable toxicity patients who meet criteria for unconfirmed disease progression per RECIST v11 while receiving toripalimab lenvatinib or their placebos will be permitted to continue treatment if their clinical status or symptoms are stable or improved as determined by the investigators or until loss of clinical benefit Patients with confirmed disease progression should discontinue toripalimab lenvatinib or their placebos
Tumor assessments will be performed at screening and during the study treatment per protocol In the absence of progression tumor assessments will continue as scheduled regardless of whether study treatment ends until confirmed disease progression or other criteria for study withdrawal are met whichever occurs first Patients who meet RECIST v11 criteria for progression should undergo tumor assessments as scheduled if clinical benefits of continuing study treatment are determined by investigators until progression is confirmed per iRECIST iCPD or the criteria for study withdrawal are met whichever occurs first
Computerized tomography CTmagnetic resonance imaging MRI scans for efficacy evaluation will be performed at baseline every 6 weeks Q6W in the first year 52 weeks and every 9 weeks Q9W in the second year after week 52
All AEs and concomitant medications during the study will be recorded An end-of-treatment EOT visit will be performed within 30 days after the last dose of study treatment or termination of study treatment is confirmed by the investigator After the EOT visit follow-up for survival telephone visit is allowed will be conducted and AEs and subsequent anti-cancer therapy will be collected
This study will enroll approximately 480 patients with unresectable advanced ICC who have received no prior systemic therapy Patients who meet the requirements will be randomly assigned to Treatment Arm A Toripalimab lenvatinib and gemcitabine-based chemotherapy or Treatment Arm B Toripalimab oral placebo and gemcitabine-based chemotherapy or Treatment Arm C Intravenous placebo oral placebo and gemcitabine-based chemotherapy
All patients will receive standard chemotherapy GEMOX or GC per Investigator decision for a maximum of 8 cycles After the completion of standard chemotherapy all patients continue to receive maintenance therapy with toripalimab injection or its placebo in combination with lenvatinib mesylate capsule or its placebo until unacceptable toxicity confirmed disease progression and loss of clinical benefit as determined by the investigators start of new anti-cancer therapy death other conditions requiring termination of study treatment or the patient meets the criteria for study withdrawal whichever occurs first
In the absence of unacceptable toxicity patients who meet criteria for unconfirmed disease progression per RECIST v11 while receiving toripalimab lenvatinib or their placebos will be permitted to continue treatment if their clinical status or symptoms are stable or improved as determined by the investigators or until loss of clinical benefit Patients with confirmed disease progression should discontinue toripalimab lenvatinib or their placebos
Tumor assessments will be performed at screening and during the study treatment per protocol In the absence of progression tumor assessments will continue as scheduled regardless of whether study treatment ends until confirmed disease progression or other criteria for study withdrawal are met whichever occurs first Patients who meet RECIST v11 criteria for progression should undergo tumor assessments as scheduled if clinical benefits of continuing study treatment are determined by investigators until progression is confirmed per iRECIST iCPD or the criteria for study withdrawal are met whichever occurs first
Computerized tomography CTmagnetic resonance imaging MRI scans for efficacy evaluation will be performed at baseline every 6 weeks Q6W in the first year 52 weeks and every 9 weeks Q9W in the second year after week 52
All AEs and concomitant medications during the study will be recorded An end-of-treatment EOT visit will be performed within 30 days after the last dose of study treatment or termination of study treatment is confirmed by the investigator After the EOT visit follow-up for survival telephone visit is allowed will be conducted and AEs and subsequent anti-cancer therapy will be collected
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None