Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593548
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Lvosidenib AK112 Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Single-arm Single-center Phase II Clinical Study of Ivosidenib AK112 Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer Efficacy and Safety Assessment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
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 is a prospective single-arm single-center Phase II clinical study In this study participants will receive Ivosidenib in combination with CapeOX chemotherapy and radiotherapy The treatment regimen is as follows participants will first receive Ivosidenib in combination with CapeOX chemotherapy during the first cycle followed by radiotherapy starting 2 weeks after medication Depending on the dose limits of normal tissue radiation Stereotactic Ablative Radiotherapy SABR large fraction radiotherapy or high-dose combined with low-dose radiotherapy will be administered to primary and metastatic lesions One week after completing radiotherapy participants will continue to receive Ivosidenib in combination with CapeOX systemic treatment If extensive primary and metastatic lesions cannot be treated with radiotherapy initially participants will continue to receive Ivosidenib in combination with CapeOX systemic treatment until the lesions shrink at which point radiotherapy may be considered
Assessments will be conducted every 2 treatment cycles after treatment initiation with multidisciplinary team MDT discussions to determine if No Evidence of Disease NED is achieved Patients achieving NED may undergo surgery or local treatment while those with stable or partial responses will continue combination therapy Patients with disease progression will discontinue study treatment Patients ineligible for surgical treatment will continue combination therapy until disease progression or until they exit the study for surgical treatment
During the study period participants will undergo safety monitoring The safety follow-up period is defined as 90 days after the last dose of Ivosidenib Safety data will be collected from the time of informed consent signing until the end of the safety follow-up period or initiation of new anti-tumor treatment whichever occurs first
Assessments will be conducted every 2 treatment cycles after treatment initiation with multidisciplinary team MDT discussions to determine if No Evidence of Disease NED is achieved Patients achieving NED may undergo surgery or local treatment while those with stable or partial responses will continue combination therapy Patients with disease progression will discontinue study treatment Patients ineligible for surgical treatment will continue combination therapy until disease progression or until they exit the study for surgical treatment
During the study period participants will undergo safety monitoring The safety follow-up period is defined as 90 days after the last dose of Ivosidenib Safety data will be collected from the time of informed consent signing until the end of the safety follow-up period or initiation of new anti-tumor treatment whichever occurs first
Detailed Description:
This is a prospective single-arm single-center Phase II clinical study In this study participants will receive Ivosidenib in combination with CapeOX chemotherapy and radiotherapy The treatment regimen is as follows participants will first receive Ivosidenib in combination with CapeOX chemotherapy during the first cycle followed by radiotherapy starting 2 weeks after medication Depending on the dose limits of normal tissue radiation Stereotactic Ablative Radiotherapy SABR large fraction radiotherapy or high-dose combined with low-dose radiotherapy will be administered to primary and metastatic lesions One week after completing radiotherapy participants will continue to receive Ivosidenib in combination with CapeOX systemic treatment If extensive primary and metastatic lesions cannot be treated with radiotherapy initially participants will continue to receive Ivosidenib in combination with CapeOX systemic treatment until the lesions shrink at which point radiotherapy may be considered
Assessments will be conducted every 2 treatment cycles after treatment initiation with multidisciplinary team MDT discussions to determine if No Evidence of Disease NED is achieved Patients achieving NED may undergo surgery or local treatment while those with stable or partial responses will continue combination therapy Patients with disease progression will discontinue study treatment Patients ineligible for surgical treatment will continue combination therapy until disease progression or until they exit the study for surgical treatment
During the study period participants will undergo safety monitoring The safety follow-up period is defined as 90 days after the last dose of Ivosidenib Safety data will be collected from the time of informed consent signing until the end of the safety follow-up period or initiation of new anti-tumor treatment whichever occurs first
Assessments will be conducted every 2 treatment cycles after treatment initiation with multidisciplinary team MDT discussions to determine if No Evidence of Disease NED is achieved Patients achieving NED may undergo surgery or local treatment while those with stable or partial responses will continue combination therapy Patients with disease progression will discontinue study treatment Patients ineligible for surgical treatment will continue combination therapy until disease progression or until they exit the study for surgical treatment
During the study period participants will undergo safety monitoring The safety follow-up period is defined as 90 days after the last dose of Ivosidenib Safety data will be collected from the time of informed consent signing until the end of the safety follow-up period or initiation of new anti-tumor treatment whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None