Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05033392
Status:
RECRUITING
Last Update Posted:
2023-06-29
First Post:
2021-08-03
Brief Title:
PD-1 Blockade With JS001 Plus Neoadjuvant Chemotherapy for GastricGastroesophageal Junction Cancer
Sponsor:
Wan He
Organization:
Shenzhen Peoples Hospital
Study Overview
Official Title:
An Open Single-center Phase II Clinical Trial Evaluating the Efficacy of PD-1 Antibody JS001 in Combination With Neoadjuvant Chemotherapy for GastricGastroesophageal Junction Cancer
Status:
RECRUITING
Status Verified Date:
2023-06
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:
PNACGEC
Brief Summary:
Gastric cancer GCincluding cardia and noncardia gastric cancer is responsible for over 480000 new cases in 2020 and an estimated 370000 deaths making it the third most frequently diagnosed cancer and the third leading cause of cancer death in China Majority of patients63 are presented with locally advanced gastric cancer stage ⅡⅢ and the prognosis is poor Previous studies have shown that patients with pathological complete responsepCR following neoadjuvant therapy have longer survival In 2019 Lancet Oncology published the FLOT4-AIO study which testified that perioperative chemotherapy with FLOT 5-FULV oxaliplatin and docetaxel regimen has improved pCR rate and prolonged progression free survivalPFS and overall survivalOS in patients with stage IIIII gastric cancer Moreover PD-1 blockade such as nivolumab or pembrolizumab in combination with chemotherapy has shown higher objective response rateORR as compared to chemotherapy alone in advanced gastric cancer The nanoparticle albumin-bound paclitaxel has been recommended as the second-line chemotherapy for unresectable or recurrent gastric cancer based on the Chinese Society of Clinical OncologyCSCO guideline When PD-1 antibody is applied albumin-bound paclitaxel is considered as a better partner since no pretreatment of corticosteroids is needed Thus the investigators plan to conduct a phase II clinical trial to evaluate the efficacy and safety of toripalimab PD-1 antibody combined with the FLOAP albumin-bound paclitaxel oxaliplatin fluorouracil and leucovorin regimen as the perioperative treatment of cT2-4 andor N GC The primary end point is pCR rate The secondary end points include disease free survivalDFS OS ORR R0 resection rate incidence of adverse eventsAE
Detailed Description:
This phase Ⅱ trial is a single-arm open-label non-randomized and single center clinical study Patients who met the inclusion criteria will receive the combination of toripalimab 160mg iv d1q2w with FLOAP fluorouracil2600mgm2 leucovorin 200mgm2 oxaliplatin 85mgm2 albumin paclitaxel 150mgm2 d1 q2w up to four cycles After the fourth cycle of the treatment the clinical efficacy and operation feasibility will be evaluated by the MDT discussions And then surgery will be performed within 4 weeks After the surgery patients will receive 4-cycle treatments of toripalimab combined with FLOAP regimen The primary end point is pCR rate The secondary end points included DFS OS ORR R0 resection rate incidence of AE
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