Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04603040
Status:
UNKNOWN
Last Update Posted:
2020-10-26
First Post:
2020-09-17
Brief Title:
A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers
Sponsor:
Shanghai Junshi Bioscience Co Ltd
Organization:
Shanghai Junshi Bioscience Co Ltd
Study Overview
Official Title:
A Single-arm Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection JS001 in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
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 single-arm multicenter phase 2 study to assess the efficacy and safety of Toripalimab Injection JS001 in patients with advanced recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines of therapy and are positive for specific markers
Patients who meet the requirements will be treated with Toripalimab injection 240 mg once every 3 weeks q3w until disease progression based on imaging according to RECIST 11 criteria judged by the investigator or intolerable toxicity or withdrawal of informed consent or withdrawal of treatment judged by the investigator or voluntarydiscontinuation of treatment by the patient with CR of more than 6 months or up to 2 years of treatment for JS001 whichever occurs first
For the case that the patient shows disease progression on imaging according to RECIST 11 as long as the investigator judges that the patient can still benefit from continued medication the treatment with Toripalimab Injection can be continued until the progression on imaging assessed by the investigator for the second time The clinical benefit is based on the results of comprehensive assessment by the investigator in combination with imaging findings and clinical condition when the patient has no intolerable toxicity or the symptoms worsen due to disease progression
Tumor assessments are performed at screening as the baseline every 6 weeks from the first dose in the first year and every 9 weeks from the second year until radiologically documented progressive disease PD or second disease progression judged by the investigator for patients with disease progression shown by first imaging but who can continue treatment judged by the investigator or withdrawal of informed consent by the patient or loss to follow-up or start of a new anti-tumor therapy or the termination of the study If a patient withdraws from the study for reasons other than disease progression including due to the AE or because the treatment interval is beyond the window and no disease progression occurs at the time of withdrawal radiographic assessments should be continued until disease progression death or start of a new anti-tumor therapy Patient medication management is based on the investigators tumor assessment
Patients who meet the requirements will be treated with Toripalimab injection 240 mg once every 3 weeks q3w until disease progression based on imaging according to RECIST 11 criteria judged by the investigator or intolerable toxicity or withdrawal of informed consent or withdrawal of treatment judged by the investigator or voluntarydiscontinuation of treatment by the patient with CR of more than 6 months or up to 2 years of treatment for JS001 whichever occurs first
For the case that the patient shows disease progression on imaging according to RECIST 11 as long as the investigator judges that the patient can still benefit from continued medication the treatment with Toripalimab Injection can be continued until the progression on imaging assessed by the investigator for the second time The clinical benefit is based on the results of comprehensive assessment by the investigator in combination with imaging findings and clinical condition when the patient has no intolerable toxicity or the symptoms worsen due to disease progression
Tumor assessments are performed at screening as the baseline every 6 weeks from the first dose in the first year and every 9 weeks from the second year until radiologically documented progressive disease PD or second disease progression judged by the investigator for patients with disease progression shown by first imaging but who can continue treatment judged by the investigator or withdrawal of informed consent by the patient or loss to follow-up or start of a new anti-tumor therapy or the termination of the study If a patient withdraws from the study for reasons other than disease progression including due to the AE or because the treatment interval is beyond the window and no disease progression occurs at the time of withdrawal radiographic assessments should be continued until disease progression death or start of a new anti-tumor therapy Patient medication management is based on the investigators tumor assessment
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?:
True
Is an FDA AA801 Violation?:
None