The Predictive Value of Complement C3 in Patients With Advanced Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Relationship Between Complement C3 Depletion and Metastatic Gastric Cancer: A Prospective Pilot Study

Conditions
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Gastric Cancer, Complement Component Deficiency, Surgery

Intervention / Treatment
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* Procedure: gastrectomy plus D2 lymphadenectomy
* Drug: S-1+Oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| C3 Depletion<br>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. | Procedure: gastrectomy plus D2 lymphadenectomy<br>* 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.<br>* Other names: D2 surgery;Drug: S-1+Oxaliplatin<br>* 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<br>* Other names: SOX regimen;|
| Non-C3 depletion<br>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. | Procedure: gastrectomy plus D2 lymphadenectomy<br>* 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.<br>* Other names: D2 surgery;Drug: S-1+Oxaliplatin<br>* 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<br>* Other names: SOX regimen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | 1-year overall survival (OS) would be regarded as primary endpoint of this study. | one year after surgery | 
| Disease-Free Survival | 1-year disease-free survival (DFS) would be also regarded as primary endpoint of this study. | One year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early complications | 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. | within 30 days after a radical operation | 
| Length of hospital stay | Time frame would cover the period from admission to discharge from hospital. An average of 4 weeks is expected. | an expected average of 4 weeks after admission | 
| Expenditure of hospitalization | The total costs during the hospitalization would be summarized. | an expected average of 4 weeks after admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, complement system, overal survival