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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425930
• Other study ID #: [2013]A-246
• Status: Completed
• Phase: N/A
• First received: April 10, 2015
• Last updated: April 21, 2015
• Start date: August 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complement Component Deficiency
• Gastric Cancer
• Stomach Neoplasms
• Surgery

Intervention

Procedure:
• gastrectomy 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.

Drug:
• S-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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	1-year overall survival (OS) would be regarded as primary endpoint of this study.	one year after surgery	Yes
Primary	Disease-Free Survival	1-year disease-free survival (DFS) would be also regarded as primary endpoint of this study.	One year after surgery	Yes
Secondary	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	No
Secondary	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	No
Secondary	Expenditure of hospitalization	The total costs during the hospitalization would be summarized.	an expected average of 4 weeks after admission	No