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

NCT ID: NCT02425930

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-04-30

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.

Conditions

Gastric Cancer; Complement Component Deficiency; Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

C3 Depletion

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.

gastrectomy plus D2 lymphadenectomy

Intervention Type: PROCEDURE

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.

S-1+Oxaliplatin

Intervention Type: DRUG

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

Non-C3 depletion

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.

gastrectomy plus D2 lymphadenectomy

Intervention Type: PROCEDURE

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.

S-1+Oxaliplatin

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Other Intervention Names

D2 surgery; SOX regimen

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Yulong He

Director of Center of Gastrointestinal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yulong He, MD

Role: PRINCIPAL_INVESTIGATOR

First Hospital, Sun Yat-sen University

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

References

Yuan K, Ye J, Liu Z, Ren Y, He W, Xu J, He Y, Yuan Y. Complement C3 overexpression activates JAK2/STAT3 pathway and correlates with gastric cancer progression. J Exp Clin Cancer Res. 2020 Jan 13;39(1):9. doi: 10.1186/s13046-019-1514-3.

Reference Type: DERIVED

PMID: 31928530 (View on PubMed)

Other Identifiers

[2013]A-246

Identifier Type: -

Identifier Source: org_study_id