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

Sun Yat-sen University

Status: Completed

Conditions: Complement Component Deficiency; Gastric Cancer; Surgery

Treatments: Procedure: gastrectomy plus D2 lymphadenectomy; Drug: S-1+Oxaliplatin

Study type: Observational

Funder types: Other

Identifiers

NCT02425930

[2013]A-246

Details and patient eligibility

About

This study is designed to investigate whether complement C3 depletion is associated with poor short-term outcomes in postoperative patients with gastric cancer.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

85 participants in 2 patient groups

C3 Depletion

Description:

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.

Treatment:

Drug: S-1+Oxaliplatin

Procedure: gastrectomy plus D2 lymphadenectomy

Non-C3 depletion

Description:

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.

Treatment:

Drug: S-1+Oxaliplatin

Procedure: gastrectomy plus D2 lymphadenectomy