Complement Component Deficiency, Gastric Cancer, Surgery
Conditions
Keywords
gastric cancer, complement system, overal survival
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.
Interventions
PROCEDUREgastrectomy plus D2 lymphadenectomy
A classic total or subtotal gastrectomy plus D2 lymph nodes dissection would be performed for all enrolled patients. Patients in both groups would undergo the identical therapeutic approach for gastric cancer, mainly decided by a multidisciplinary treatment group in our center.
DRUGS-1+Oxaliplatin
A postoperative systemic chemotherapy would be performed for some subjects who have advanced gastric cancer. The concrete chemo regimen for adjuvant chemotherapy is also determined by a MDT group. Generally, SOX chemo regimen is the first-line treatment in our center, as following described: * S-1: 40\ 60mg bid，po, Day1\ 14 （S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid） * Oxaliplatin: 130mg/m2，iv drip for 2h，Day1
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Pathological diagnosis of gastric adenocarcinoma * Radical operation and adjuvant chemotherapy endurable * Informed consent approved
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Expenditure of hospitalization | an expected average of 4 weeks after admission | The total costs during the hospitalization would be summarized. |
Countries
China
Outcome results
None listed