NCT02425930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

1.5 years

First QC Date

April 10, 2015

Last Update Submit

April 21, 2015

Conditions

Gastric CancerComplement Component DeficiencySurgery

Keywords

gastric cancercomplement systemoveral survival

Outcome Measures

Primary Outcomes (2)

  • Overall Survival

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

    one year after surgery

  • Disease-Free Survival

    1-year disease-free survival (DFS) would be also regarded as primary endpoint of this study.

    One year after surgery

Secondary Outcomes (3)

  • Early complications

    within 30 days after a radical operation

  • Length of hospital stay

    an expected average of 4 weeks after admission

  • Expenditure of hospitalization

    an expected average of 4 weeks after admission

Study Arms (2)

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 lymphadenectomyDrug: S-1+Oxaliplatin

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 lymphadenectomyDrug: S-1+Oxaliplatin

Interventions

gastrectomy plus D2 lymphadenectomyPROCEDURE

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.

Also known as: D2 surgery
C3 DepletionNon-C3 depletion
S-1+OxaliplatinDRUG

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

Also known as: SOX regimen
C3 DepletionNon-C3 depletion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Pathological diagnosis of gastric adenocarcinoma
  • Radical operation and adjuvant chemotherapy endurable
  • Informed consent approved

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • 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.

    PMID: 31928530DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastrectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Yulong He, MD

    First Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Center of Gastrointestinal Surgery

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 24, 2015

Study Start

August 1, 2013

Primary Completion

February 1, 2015

Study Completion

April 1, 2015

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations

CN(1)