Gastric CancerNCT02425930
The Predictive Value of Complement C3 in Patients With Advanced Gastric Cancer
An observational study of Gastric Cancer and Complement Component Deficiency, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Complement Component Deficiency, Surgery
- What is being tested?
- gastrectomy plus D2 lymphadenectomy and S-1+Oxaliplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Pathological diagnosis of gastric adenocarcinoma
- Radical operation and adjuvant chemotherapy endurable
- Informed consent approved
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: 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.
Read the 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
- Being tested
- gastrectomy plus D2 lymphadenectomy, S-1+Oxaliplatin
- Keywords
- gastric cancer, complement system, overal survival
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastrectomy plus D2 lymphadenectomyProcedure or surgery
Also called D2 surgery
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+OxaliplatinDrug
Also called SOX regimen
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: gastrectomy plus D2 lymphadenectomy; Drug: 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. Receives: Procedure: gastrectomy plus D2 lymphadenectomy; Drug: S-1+Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
1-year overall survival (OS) would be regarded as primary endpoint of this study.
Measured: one year after surgery
Disease-Free Survival
1-year disease-free survival (DFS) would be also regarded as primary endpoint of this study.
Measured: One year after surgery
Secondary outcomes (3)
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.
Measured: within 30 days after a radical operation
Length of hospital stay
Time frame would cover the period from admission to discharge from hospital. An average of 4 weeks is expected.
Measured: an expected average of 4 weeks after admission
Expenditure of hospitalization
The total costs during the hospitalization would be summarized.
Measured: an expected average of 4 weeks after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startAug 2013
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yulong He, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yulong He, MD, Principal investigator, First Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425930
- Sponsor's protocol ID
- [2013]A-246
- Status last verified
- Apr 2015
- First submitted
- 10 Apr 2015
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31928530
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Complement C3 Depletion and Metastatic Gastric Cancer: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT02425930
- Acronym / sponsor ID
- [2013]A-246
- Conditions
- Gastric Cancer, Complement Component Deficiency, Surgery
- Keywords
- gastric cancer, complement system, overal survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C3 Depletion | – | Procedure: gastrectomy plus D2 lymphadenectomy, Drug: S-1+OxaliplatinPatients 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. |
| Non-C3 depletion | – | Procedure: gastrectomy plus D2 lymphadenectomy, Drug: S-1+OxaliplatinPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Pathological diagnosis of gastric adenocarcinoma
- Radical operation and adjuvant chemotherapy endurable
- Informed consent approved
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastrectomy plus D2 lymphadenectomyAlso: D2 surgeryA 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. | Procedure or surgery | C3 Depletion, Non-C3 depletion |
| S-1+OxaliplatinAlso: SOX regimenA 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 | Drug | C3 Depletion, Non-C3 depletion |
Primary outcome
Overall Survival
Time frame: one year after surgery
1-year overall survival (OS) would be regarded as primary endpoint of this study.
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.
3 secondary outcomes
Early complications
Time frame: within 30 days after a radical operation
Length of hospital stay
Time frame: an expected average of 4 weeks after admission
Expenditure of hospitalization
Time frame: an expected average of 4 weeks after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Derived from this study: PubMed 31928530Yuan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yulong He, MD principal investigator
First Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Complement Component Deficiency, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: one year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02425930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015; AzTrials last refreshed its copy on 28 Oct 2026.