Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Complement Component Deficiency

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Complement System Proteins

Complement C3

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.

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.

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.

gastrectomy plus D2 lymphadenectomy

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

S-1+Oxaliplatin

Yulong He, MD

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

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.

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

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

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

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

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.

Time frame would cover the period from admission to discharge from hospital. An average of 4 weeks is expected.

The total costs during the hospitalization would be summarized.

First Affiliated Hospital, Sun Yat-Sen University

Director of Center of Gastrointestinal Surgery

Symptoms and General Pathology

Rectal Neoplasms

Recurrence

Disease Attributes

For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery without neoadjuvant chemoradiotherapy.

For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery following neoadjuvant chemoradiotherapy.

neoadjuvant chemoradiotherapy

Jiagang Han, MD

Jiagang Han, Professor

Zhenjun Wang, professor

Guanghui WEI, Professor

For now, neoadjuvant chemoradiotherapy is routinely performed for T3N1-2M0 rectal cancer. However, there are lots of complications following neoadjuvant chemoradiotherapy, such as Wound-related complications, anastomotic leakage, anastomotic stenosis, sexual dysfunction, testicular or ovary failure. Patients undergoing resection for rectal cancer had low rates of local recurrence and long disease-free survival regardless of whether an APR, CAA or low AR was performed. The main purpose of preoperative radiotherapy is to lower the local recurrence. For the T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, we suppose might not necessary to receive neoadjuvant chemoradiotherapy, for operation can achieve the negative circumferential resection margin.

Surgery Without Neoadjuvant Chemoradiotherapy Compared With Neoadjuvant Chemoradiotherapy for Rectal Cancer With Negative Circumferential Resection Margin Based on MRI Assessment, a Perspective Multicenter Randomized Controlled Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Predictive Value of Complement C3 in Patients With Advanced Gastric Cancer	NCT02425930	Gastric Cancer Complement Comp... Surgery	gastrectomy plu... S-1+Oxaliplatin	18 Years - 75 Years	First Affiliated Hospital, Sun Yat-Sen University
The Predictive Value of Complement C3 in Patients With Advanced Gastric Cancer	NCT02425930	Gastric Cancer Complement Comp... Surgery	gastrectomy plu... S-1+Oxaliplatin	18 Years - 75 Years	First Affiliated Hospital, Sun Yat-Sen University
Surgery Without Neoadjuvant Chemoradiotherapy Compared With Neoadjuvant Chemoradiotherapy for Rectal Cancer With Negative Circumferential Resection Margin Based on MRI Assessment, a Perspective Multicenter Randomized Controlled Trial	NCT03504449	Circumferential... Intraoperative ... Local Recurrenc... Disease-free Su... Overal Survival	neoadjuvant che...	18 Years - 75 Years	Beijing Chao Yang Hospital
Surgery Without Neoadjuvant Chemoradiotherapy Compared With Neoadjuvant Chemoradiotherapy for Rectal Cancer With Negative Circumferential Resection Margin Based on MRI Assessment, a Perspective Multicenter Randomized Controlled Trial	NCT03504449	Circumferential... Intraoperative ... Local Recurrenc... Disease-free Su... Overal Survival	neoadjuvant che...	18 Years - 75 Years	Beijing Chao Yang Hospital

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