Ignite Creation Date:
2024-05-06 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05180734
Status:
RECRUITING
Last Update Posted:
2023-03-20
First Post:
2021-11-08
Brief Title:
PD1 Combined With Chemotherapy for Adjuvant Treatment of Gastric Cancer
Sponsor:
Shanghai Junshi Bioscience Co Ltd
Organization:
Shanghai Junshi Bioscience Co Ltd
Study Overview
Official Title:
An International Multicenter Randomized Double-blind Phase III Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection Combined With Postoperative Adjuvant Chemotherapy Versus Placebo Combined With Postoperative Adjuvant Chemotherapy in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma After Radical Gastrectomy
Status:
RECRUITING
Status Verified Date:
2023-03
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 international multicenter randomized double-blind phase III study intends to recruit 680 patients who have received radical gastrectomy R0 resection D2 or more extended lymphadenectomy with postoperative pathological stage II or III AJCC Cancer Staging Manual 8th Edition gastric or EGJ adenocarcinoma to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy
Detailed Description:
This is an international multicenter randomized double-blind phase III study plans to recruit 680 patients who received radical gastrectomy R0 D2 or higher lymphadenectomy with postoperative pathological stage II T4aN0M0 or III the 8th Edition American Joint Committee on Cancer AJCC Cancer Staging Manual gastric adenocarcinoma and gastroesophageal junction adenocarcinoma and the study intends to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy
Patients meeting the inclusion criteria will be 11 randomized into JS001-chemotherapy group and placebo-chemotherapy group The random stratification factors include adjuvant chemotherapeutic regimens XELOX versus SOX and tumor anatomical sites gastric adenocarcinoma versus gastroesophageal junction adenocarcinoma
The study treatment will be initiated 4-6 weeks after surgery and the investigator will select XELOX Oxaliplatin capecitabine or SOX Oxaliplatin S-1 tegafur gimeracil and oteracil potassium as the adjuvant chemotherapeutic regimen given as 3-week cycles for up to 8 cycles based on each patients condition JS001placebo will be given for up to 17 cycles after surgery until intolerable toxicity disease recurrence patients withdrawal of consent investigators judgment that the patient needs to be withdrawn from the study treatment or death whichever comes first
Safety evaluation including vital signs ECOG score physical examination and laboratory examinations will be performed on a regular basis during the treatment
This study will end after the main analysis node of DFS and unblinding for analysis are achieved or 5 years after enrollment of the last patient whichever comes first The Sponsor is entitled to terminate the study at any time due to specific reasons e g major safety issues force majeure etc
Radiological follow-up tumor response evaluation will be performed once every 12 weeks 7 days within the first 5 years after randomization and once per year subsequently until disease recurrence or death When symptoms or signs of suspected recurrencemetastasis occur the radiological evaluation can be performed at any time Disease recurrence is defined as local recurrence or distant metastases with clear radiological evidence CT or MRI
Survival follow-up it will be performed once every 12 weeks after disease recurrence until patients withdrawal of informed consent loss to follow-up or death whichever comes first
Safety follow-up adverse events will be closely followed up and recorded until 60 days after the last dose of treatment or the end of study follow-up death loss to follow-up withdrawal of consent form and the end of study whichever comes first
Patients meeting the inclusion criteria will be 11 randomized into JS001-chemotherapy group and placebo-chemotherapy group The random stratification factors include adjuvant chemotherapeutic regimens XELOX versus SOX and tumor anatomical sites gastric adenocarcinoma versus gastroesophageal junction adenocarcinoma
The study treatment will be initiated 4-6 weeks after surgery and the investigator will select XELOX Oxaliplatin capecitabine or SOX Oxaliplatin S-1 tegafur gimeracil and oteracil potassium as the adjuvant chemotherapeutic regimen given as 3-week cycles for up to 8 cycles based on each patients condition JS001placebo will be given for up to 17 cycles after surgery until intolerable toxicity disease recurrence patients withdrawal of consent investigators judgment that the patient needs to be withdrawn from the study treatment or death whichever comes first
Safety evaluation including vital signs ECOG score physical examination and laboratory examinations will be performed on a regular basis during the treatment
This study will end after the main analysis node of DFS and unblinding for analysis are achieved or 5 years after enrollment of the last patient whichever comes first The Sponsor is entitled to terminate the study at any time due to specific reasons e g major safety issues force majeure etc
Radiological follow-up tumor response evaluation will be performed once every 12 weeks 7 days within the first 5 years after randomization and once per year subsequently until disease recurrence or death When symptoms or signs of suspected recurrencemetastasis occur the radiological evaluation can be performed at any time Disease recurrence is defined as local recurrence or distant metastases with clear radiological evidence CT or MRI
Survival follow-up it will be performed once every 12 weeks after disease recurrence until patients withdrawal of informed consent loss to follow-up or death whichever comes first
Safety follow-up adverse events will be closely followed up and recorded until 60 days after the last dose of treatment or the end of study follow-up death loss to follow-up withdrawal of consent form and the end of study whichever comes first
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