Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371274
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-02
Brief Title:
A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC
Sponsor:
First Affiliated Hospital of Zhejiang University
Organization:
First Affiliated Hospital of Zhejiang University
Study Overview
Official Title:
Efficacy and Safety Study of Oral All-trans Retinoic Acid Combined With Toripalimab in Patients With Inoperable Locally Advanced Recurrent or Metastatic Triple-negative Breast Cancer Who Had Failed Prior Second-line or Higher Standard Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
To evaluate the clinical efficacy and safety of oral all-trans retinoic acid in combination with toripalimab in patients with locally advanced recurrent or metastatic triple-negative breast cancer who had failed second-line and subsequent therapy
Detailed Description:
The study is designed as a single arm open-label mono-center exploratory trial aiming to evaluate the clinical efficacy and safety of oral all-trans retinoic acid in combination with toripalimab in patients with locally advanced unresectable recurrent or metastatic triple-negative breast cancer who had failed second-line and subsequent standard treatments 32 subjects are planned to be enrolled Eligible participants are subjected to take all-trans retinoic acid orally at a dose of 150 mgm2 per day twice a day for three consecutive days per cycle d0d2 and intravenous infusion of PD-1 monoclonal antibody at a dose of 240 mg on day 1 of each cycle d1 with cycles repeated every 3 weeks until disease progression death loss to follow-up intolerable toxicity or meeting other withdrawal or termination criteria whichever occurs first for a maximum duration of 2 years Each subjects study process includes a screening period within 28 days a treatment period and a follow-up period Subjects will sign the informed consent form and complete all baseline assessments during the screening period Qualified subjects will enter the treatment period followed by the survival follow-up every 3 months after the completion of the treatment period Tumor assessments contrast-enhanced CT will be conducted every 2 cycles 6 weeks during the combination treatment period and efficacy evaluation will be based on RECIST 11 criteria Moreover iORR and iPFS were assessed by investigators based on iRECIST criteria Adverse events will be assessed using NCI-CTCAE version 50 with observation of adverse events up to 30 days after the last treatment
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?:
False
Is an FDA AA801 Violation?:
None