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Completed

NCT Number: NCT02425930

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

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

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Key information

Conditions

Gastric Cancer Complement Component Deficiency Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gastrectomy plus D2 lymphadenectomy

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.

Other names: D2 surgery

S-1+Oxaliplatin

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

Other names: SOX regimen

Primary outcomes

  1. Overall Survival

    Time frame: one year after surgery

    1-year overall survival (OS) would be regarded as primary endpoint of this study.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Expenditure of hospitalization

    Time frame: an expected average of 4 weeks after admission

    The total costs during the hospitalization would be summarized.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 24, 2015
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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