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

April 21, 2015 updated by: Yulong He, First Affiliated Hospital, Sun Yat-Sen University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have a confirmed pathological diagnosis of gastric adenocarcinoma would be selected for further observation. Those patients who subsequently underwent a radical tumor resection can be included for final analysis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • D2 surgery
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
Other Names:
  • SOX regimen
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.
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.
Other Names:
  • D2 surgery
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
Other Names:
  • SOX regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: one year after surgery
1-year overall survival (OS) would be regarded as primary endpoint of this study.
one year after surgery
Disease-Free Survival
Time Frame: One year after surgery
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
Time Frame: 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.
within 30 days after a radical operation
Length of hospital stay
Time Frame: 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.
an expected average of 4 weeks after admission
Expenditure of hospitalization
Time Frame: an expected average of 4 weeks after admission
The total costs during the hospitalization would be summarized.
an expected average of 4 weeks after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Principal Investigator: Yulong He, MD, First Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 10, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Estimate)

April 24, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2013]A-246

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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