The Predictive Value of Complement C3 in Patients With Advanced Gastric Cancer
- Conditions
- SurgeryGastric CancerComplement Component Deficiency
- Interventions
- Procedure: gastrectomy plus D2 lymphadenectomyDrug: S-1+Oxaliplatin
- Registration Number
- NCT02425930
- Lead Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Brief Summary
This study is designed to investigate whether complement C3 depletion is associated with poor short-term outcomes in postoperative patients with gastric cancer.
- Detailed Description
The complement system plays an important role in the development of digestive malignancies. The complement C3 is the point of convergence for the three complement activation pathways. However, the concrete effect of C3 in the development of gastric cancer is still obscured. This study is designed to explore whether complement C3 can be regarded as a predictive factor of postoperative outcomes for postoperative patients with gastric cancer.
This study is designed as a prospective cohort study and included consecutively treated patients. The perioperative plasma value of complement components, such as C3, C4, and CH50, are detected to explore the incidence rate of complement depletion. All enrolled patients are divided into two groups mainly according to the levels of preoperative C3 levels (C3 depletion and Non-C3 depletion groups). The primary endpoints are the 1-year overall survival and disease-free survival, while the secondary endpoints are postoperative complications, length of hospital stay, and hospital charges.
This study would be helpful to confirm the role of complement depletion in anticipated outcomes of postoperative patients with gastric cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- Pathological diagnosis of gastric adenocarcinoma
- Radical operation and adjuvant chemotherapy endurable
- Informed consent approved
- Age <18 or >75 years old
- Pregnancy or lactating woman
- Any primary diagnosis other than gastric cancer
- Confirmed complement deficiency due to immunity dysfunction or other disease
- Required blood transfusion, plasmapheresis, or emergent operation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description C3 Depletion S-1+Oxaliplatin Patients with persistent low-level of complement C3 within the perioperative period would be assigned into this main observational group. After a careful multidisciplinary treatment (MDT) discussion, a radical operation with gastrectomy plus D2 lymphadenectomy would be performed, followed by an adjuvant chemotherapy if required. Generally, SOX chemo regimen (S-1+Oxaliplatin) would be first considered for the candidates. C3 Depletion gastrectomy plus D2 lymphadenectomy Patients with persistent low-level of complement C3 within the perioperative period would be assigned into this main observational group. After a careful multidisciplinary treatment (MDT) discussion, a radical operation with gastrectomy plus D2 lymphadenectomy would be performed, followed by an adjuvant chemotherapy if required. Generally, SOX chemo regimen (S-1+Oxaliplatin) would be first considered for the candidates. Non-C3 depletion gastrectomy plus D2 lymphadenectomy Patients with normal plasma values of complement C3 within the perioperative period would be assigned into this control group. Those patients would undergo the same decision making process to determine the final treatment plan. Non-C3 depletion S-1+Oxaliplatin Patients with normal plasma values of complement C3 within the perioperative period would be assigned into this control group. Those patients would undergo the same decision making process to determine the final treatment plan.
- Primary Outcome Measures
Name Time Method Overall Survival one year after surgery 1-year overall survival (OS) would be regarded as primary endpoint of this study.
Disease-Free Survival One year after surgery 1-year disease-free survival (DFS) would be also regarded as primary endpoint of this study.
- Secondary Outcome Measures
Name Time Method Length of hospital stay an expected average of 4 weeks after admission Time frame would cover the period from admission to discharge from hospital. An average of 4 weeks is expected.
Early complications within 30 days after a radical operation Early postoperative events should include intra-abdominal infection, postoperative hemorrhage, anastomotic leak, surgical site infection, ileus, and so on. Number of such events would be recorded to calculate incidence.
Expenditure of hospitalization an expected average of 4 weeks after admission The total costs during the hospitalization would be summarized.
Trial Locations
- Locations (1)
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China