RuiLiu
Tianjin, Tianjin Municipality, 300060, China
Location status: Recruiting
NCT Number: NCT04908566
The FOLFIRINOX regimen has become the standard treatment regimen for advanced colorectal cancer, advanced pancreatic cancer and postoperative adjuvant treatment for pancreatic cancer. With the continuous exploration of Chinese scholars, it has also revised the modified dose suitable for the physical fitness of the Chinese people, which is well tolerated and has a clear efficiency. The drugs in this program are all standard treatment drugs for gastric cancer.
In 2020, JAMA Network Open and JAMA Oncology successively reported the application of FOLFIRINOX in the perioperative period of gastric cancer and the late-stage results of gastric cancer, and they obtained very amazing data respectively.
According to the results of CheckMate-649, the FDA approved Nivolumab combined chemotherapy for first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression. At the same time, this is also the first first-line immunotherapy approved by the FDA for gastric cancer.However, there is no definite conclusion about the preoperative neoadjuvant or perioperative clinical research, so it is necessary to explore the efficacy of PD-1 antibody in the perioperative period.
This study is a single-center, randomized, controlled phase II clinical study. The primary endpoint of the study is the perioperative administration of mFOLFIRINOX regimen combined with PD-1 antibody and D2 radical resection for the treatment of resectable advanced gastric cancer. The deep tumor remission rate (TRG0 and TRG1) , secondary endpoints include pCR rate, 3-year DFS rate, safety, R0 resection rate, D2 radical resection rate, 5-year DFS rate, 5-year OS rate.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Tianjin, Tianjin Municipality, 300060, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood routine: white blood cells (WBC) <3.0×109/L, neutrophils (ANC) <1.5×109/L, platelets (PLT) <100×109/L, hemoglobin (Hb) <90g/L.
Liver and kidney function: total bilirubin (TBIL)>1.5 times the upper limit of the normal value; urea nitrogen (BUN)>1.5 times the upper limit of the normal value;Creatinine (Cr)>1.5 times the upper limit of the normal value;Alanine aminotransferase and aspartate aminotransferase (ALT and AST)> 3 times the upper limit of the normal value (without liver metastasis);Alanine aminotransferase and aspartate aminotransferase (ALT and AST)> 5 times the upper limit of the normal value (for liver metastases);
Give 240 mg of PD-1 antibody before each cycle of chemotherapy, d1; Chemotherapy regimen: irinotecan 150mg/m2, d1; fluorouracil 2400 mg/m², d1-2, continuous pumping for 46 hours; leucovorin 200 mg/m², d1; oxaliplatin 65 mg/m², d1; PD-1 antibody repeats once every 3 weeks; Chemotherapy is repeated every 2 weeks. 4 cycles before surgery. 4 cycles after operation。
Give 240 mg of PD-1 antibody before each cycle of chemotherapy, d1; Chemotherapy regimen: oxaliplatin 130 mg/m², d1, ticgio 40-60mg bid, d1-14 q3w;Repeat once every 3 weeks.
2-4 cycles before surgery. The perioperative period was 8 cycles.
Time frame: Surgery
Time frame: Surgery
Time frame: progression of disease (PD) or death from any cause within 3 years
Time to relapse or progression of disease (PD) or death from any cause within 3 years from subject screening to first recorded
Time frame: progression of disease (PD) or death from any cause within 5 years
Time to relapse or progression of disease (PD) or death from any cause within 5 years from subject screening to first recorded
Contact information is provided by the study sponsor or research team.
Tianjin Medical University Cancer Institute and Hospital
Other
Immune Checkpoint Inhibitor PD-1 Antibody Combined With Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX) Regimen vs. PD-1 Antibody Combined With Oxaliplatin, Tigio (SOX) Regimen During Perioperative Period A Randomized Controlled Phase II Clinical Study for the Treatment of Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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