Clinical Trials Logo

Clinical Trial Summary

Gastric cancer (GC),including cardia and noncardia gastric cancer, is responsible for over 480,000 new cases in 2020 and an estimated 370,000 deaths, making it the third most frequently diagnosed cancer and the third leading cause of cancer death in China. Majority of patients(63%) are presented with locally advanced gastric cancer (stage Ⅱ/Ⅲ) and the prognosis is poor. Previous studies have shown that patients with pathological complete response(pCR) following neoadjuvant therapy have longer survival. In 2019, Lancet Oncology published the FLOT4-AIO study which testified that perioperative chemotherapy with FLOT (5-FU/LV, oxaliplatin and docetaxel) regimen has improved pCR rate and prolonged progression free survival(PFS) and overall survival(OS) in patients with stage II/III gastric cancer. Moreover, PD-1 blockade such as nivolumab or pembrolizumab in combination with chemotherapy has shown higher objective response rate(ORR) 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 Oncology(CSCO) 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 and/or N+ GC. The primary end point is pCR rate. The secondary end points include disease free survival(DFS), OS, ORR, R0 resection rate, incidence of adverse events(AE).


Clinical Trial 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, d1,q2w) with FLOAP (fluorouracil,2600mg/m2; leucovorin, 200mg/m2; oxaliplatin, 85mg/m2; albumin paclitaxel, 150mg/m2, 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 Design


Related Conditions & MeSH terms


NCT number NCT05033392
Study type Interventional
Source Shenzhen People's Hospital
Contact Wan He, PhD
Phone +8618823719462
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date September 1, 2021
Completion date September 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT01950572 - Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Not yet recruiting NCT04949737 - Prevalence of Helicobacter Pylori Infection and Gastric Cancer in the West Indies
Not yet recruiting NCT04351867 - A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer Phase 3
Recruiting NCT02887612 - ctDNA for Prediction of Relapse in Gastric Cancer
Active, not recruiting NCT02930291 - The Effect of Preoperative Inflammation-based Scores on Postoperative Morbidity and Mortality for Laparoscopic Gastrectomy
Completed NCT02649348 - Effects of Prehabilitation in Gastric Cancer Patients With Metabolic Syndrome on Perioperative Outcome N/A
Recruiting NCT02310230 - An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy N/A
Active, not recruiting NCT01609309 - Multicenter Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer (CLASS-01) Phase 3
Completed NCT00375999 - Docetaxel and Epirubicin in Advanced Gastric Cancer Phase 2
Completed NCT00382720 - Docetaxel and Oxaliplatin in Gastric Cancer Phase 2
Completed NCT00980382 - A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma Phase 1/Phase 2
Completed NCT04539769 - Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes Phase 2
Active, not recruiting NCT02930278 - The Effect of Preoperative Hemotologic Markers on Postoperative Long-term and Short-term Outcomes for Laparoscopic Gastrectomy
Active, not recruiting NCT02845986 - Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Gastric Cancer Phase 2
Completed NCT02902575 - The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy N/A
Recruiting NCT04222114 - Comparing the Efficacy and Safety of Intra-peritoneal Infusion of Catumaxomab and Treatment of Investigator Choice in Patients With Advanced Gastric Carcinoma With Peritoneal Metastasis Phase 3
Completed NCT01234324 - ECX + Panitumumab vs. ECX Alone in Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction Phase 2
Completed NCT02370849 - Cisplatin and S-1 With or Without Nimotuzumab in Untreated Advanced Gastric Adenocarcinoma Phase 2
Completed NCT00390416 - Study of Docetaxel, Cisplatin, and Fluorouracil (Modified DCF) With Bevacizumab in Patients With Unresectable or Metastatic Gastroesophageal Adenocarcinoma Phase 2
Completed NCT00374985 - Safety and Efficacy of Neoadjuvant Radiochemotherapy in Adenocarcinoma of the Gastric-oesophageal Junction Phase 1/Phase 2