NCT04351867

A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer

The Efficacy and Safety of Postoperative Chemotherapy With Docetaxel Plus Oxaliplatin and Capecitabine Versus Oxaliplatin Plus Capecitabine for Postoperative Pathological Stage IIIB/IIIC Gastric Adenocarcinoma: a Randomised, Phase 3 Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: LiNing · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was a prospective, randomized, controlled phase III clinical study to evaluate the efficacy and safety of docetaxel plus oxaliplatin and capecitabine versus oxaliplatin plus capecitabine in the treatment of gastric or gastroesophageal junction adenocarcinoma with postoperative pathological stage IIIB and IIIC.

Detailed description

In 2019, CSCO guidelines grade I recommend gastric or gastroesophageal junction adenocarcinoma patients, after D2 R0 resection, whose postoperative pathological stage was III treated with XELOX as an adjuvant chemotherapy. However, some retrospective clinical studies in China suggest that the 3-year DFS rate of XELOX program as an adjuvant postoperative chemotherapy program is still low, and the risk of recurrence is higher for patients with postoperative pathological stage IIIB/IIIC.In recent years, the success of the JACCRO GC-07 trial has provided evidence for the value of Taxoids in postoperative adjuvant therapy of gastric cancer. In the FLOT4 trial, the FLOT improved the DFS rate by 3 years compared with the ECF/ECX. At present, there is no clinical study data to prove whether the combined three-drug regimen can further reduce the risk of postoperative recurrence and improve the treatment effect compared with oxaliplatin combined capecitabine two-drug regimen for patients with high postoperative recurrence risk (patients with postoperative pathological stage IIIB/IIIC). Therefore, the investigators carried out this trial.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	docetaxel plus oxaliplatin and capecitabine	docetaxel 50mg/㎡ ivgtt. d1+oxaliplatin 100mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d
DRUG	oxaliplatin plus capecitabine	oxaliplatin 130mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d

Timeline

• Start date: 2020-09-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2020-04-17
• Last updated: 2020-07-16

Locations

1 site across 1 country: China