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Digestive System Neoplasms

low calorie, low nitrogen parenteral nutrition for patient with NRS score 3

Wen-hua Zhan, MD,FACS

Zhu-Ming Jiang, MD, FACS

The study is designed to investigate the influence of parenteral nutrition (PN) with low nitrogen and calorie supply on the clinical outcome of patients after an operation compared to that of traditional PNs.

Wretlind from Sweden invented fat emulsion as early as 1961, which has been applied to parenteral nutrition. Dudrick and Wilmore from America introduced intravenous nutrition containing carbohydrates and amino acids, which was termed as high intravenous nutrition in 1967. Afterwards, it was proven that this treatment cannot improve clinical outcome but increases complications, such as infection, etc. Because of the action of catecholamine and corticosteroids under stress after an operation, insulin resistance becomes a main indicator of endocrine problems for patients. Under such circumstances, even intake of glucose at physiological doses can result in hyperglycosemia and increase the incidence of complications of infection and metabolism. Overseas and domestic scholars studied parenteral nutrition (PN) with low nitrogen and calorie supply long ago, and the results revealed that PN with low nitrogen and calorie supply can significantly decrease oxygen consumption of patients under stress of an operation, alleviate the inflammation response, reduce the rate of cholestasis and cut the treatment cost during hospitalization. On the other hand, catabolism of protein significantly increases after operation and trauma, but it cannot be simply corrected by high dose amino acid intake. Contrarily, improperly increasing of the intake of amino acids aggravates metabolism further. A domestic study on PN with a low calorie supply has revealed benefits on the clinical outcome of patients after an operation, such as a domestic randomised controlled study that has proven that intravenous nutrition with a low nitrogen and calorie supply significantly lowered the level of blood glucose, cut nutrition related medicine costs, shortened the length of hospital stay and reduced the incidence of phlebitis after operation, and also has the tendency to reduce the incidence of complications after an operation. Meta analysis has revealed that PN with a low nitrogen and calorie supply can control blood glucose better and may reduce the incidence of infection related complications, and has the tendency of shortening the length of hospital stay.

The development of all-in-one PN has experienced the process of sequential single bottle infusion, poly-bottle serial infusion, hospital prepared all-in-one solution and industrialized three compartment bags, and currently, the utilization of industrialized three compartment bags has been the dominant tendency of clinical parenteral nutrition among countries in Europe and Asia. Domestically Kabiven peripheral (FK, Germany, 1440 ml H20040008, 1920 ml H20040019) are the first three compartment bags, which is a pre-filling standard all-in-one nutrition solution. The two specifications (1440 ml,1920 ml) first launched to the market already satisfy most demands of PN support for patients, and provide PN with a low nitrogen and calorie supplying administration platform for patients after operation, spare time for the preparation of all-in-one nutrition solution, and avoid preparing such solutions under the common clean condition in hospitals.

Up to now, there is no report of a randomized controlled study about the utilization of three compartment bags domestically.

The Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients

Comparing With Traditional Nitrogen Calorie Parenteral Nutrition Support, the Impact of Low Calorie and Low Nitrogen Intake on the Clinical Outcome of Gastrointestinal Postoperative Patients, Multicentre Post-Marketing Clinical Study

Guangzhou S Y S Medical School hospital

Wuhan TongJi Hospital

Beijing 301 hospital

Jie-Ping Wu Medical Foundation

Sino-Swed Pharmaceutical Corporation

ZM Jiang

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Antibodies

Antibodies, Monoclonal

Capecitabine

Immunoglobulins

Immunologic Factors

Antimetabolites

Patients receive 2 cycles of Capecitabine and Oxaliplatin (CapeOx) chemotherapy and evaluated with rectum Magnetic Resonance Imaging (MRI). Patients with more than 20% regression of maximum diameter of rectal tumor in MRI image will entry into next step of rectal artery infusion of Oxaliplatin and oral Capecitabine（1000mg/㎡）with anti-PD1 antibody（200mg）every 3 weeks for 2 cycles.Then those patients will receive rectectomy including anterior resection or abdominoperineal resection by open or laparoscopy with TME.

Drug: Oxaliplatin Oxaliplatin 130mg/m2 for inducing chemotherapy in Day 1 every 3 weeks and repeat for two cycles.

The dose of oxaliplatin used for rectal artery infusion was uncertain because there were no previous study. We design this study with Oxaliplatin 85mg/㎡for rectal artery infusion chemotherapy in Day 1 every 3 weeks and repeat for 2 cycles, based on intravenous chemotherapy regimens recommended by NCCN（mFolfox6）.If there were severe side effects caused by oxaliplatin observed within first 5 patients, we would decreasing the dose of oxaliplatin depending on the multidisciplinary discussion of researchers.

We acknowledged that our study did not determine the most appropriate dosage of oxaliplatin used for artery infusion, but rather performed a novel therapeutic method for microsatellite stable locally advanced rectal cancer.

Include anterior resection or abdominoperineal resection by open or laparoscopy with Total Mesorectal Excision (TME).

Rectectomy

Oral Capecitabine 1000 mg/m2 twice daily combined with oxaliplatin chemotherapy in Day 1 to Day 14 every 3 weeks and repeat for 4 cycles.

Anti-PD1 antibody 200mg/m2 in Day 2 after Rectal Artery Infusion Chemotherapy. Repeat every 3 weeks for 2 cycles.

Anti-PD-1 monoclonal antibody

Li Jun, MD

Jiao Yurong

Yurong Jiao

Jun Li, MD

The purpose of this study is to explore whether rectal artery infusion chemotherapy combined with anti-PD1 antibody is an effective neoadjuvant therapy for the microsatellite stable locally advanced rectal cancer.

Neoadjuvant chemoradiation is the standard treatment for locally advanced rectal cancer. Neoadjuvant chemoradiotherapy can achieve a pathological complete response rate (pCR) of about 20%. However, radiotherapy can cause tissue edema and fibrosis, increasing the risk of anastomotic leakage, resulting in rectal, urinary, and sexual dysfunction. Neoadjuvant chemotherapy or immunotherapy can avoid these adverse reactions, but the pCR rate of chemotherapy is significantly lower than that of neoadjuvant radiotherapy, and immunotherapy is less effective for MSS patients with weak immunogenicity. This study is a prospective, single-arm, single-center trial. The study will enhance the local killing effect of oxaliplatin through rectal artery infusion and induce immunogenic cell death (ICD) to enhance tumor antigen presentation, and then combine anti-PD1 antibody for neoadjuvant therapy. The study will address whether this treatment combination achieves pCR rates that are non-inferior to neoadjuvant RT for MSS-type locally advanced rectal cancer. It is known that the effective rate of oxaliplatin-containing intravenous chemotherapy for colorectal cancer is about 60%. In this study, 2 cycles of XELOX induction chemotherapy were firstly performed to screen out patients who were sensitive to chemotherapy. These patients were then infused with oxaliplatin via the superior rectal artery and oral capecitabine, combined with anti-PD1 antibody therapy for 2 cycles, and then underwent TME surgery. The primary endpoint of the study was the pCR rate.

The pCR rate of neoadjuvant chemoradiotherapy is about 20% (null hypothesis). Assuming that the pCR of the RAIC scheme in this study would be in the range of 15%-35%. Using Simon's two-stage design, a total of 37 patients would provide 80% power at a one sided 5% alpha level. Considering the drop rate of 10%, 38 patients would be included (64 cases to be screened) in this study. 10 cases (17 cases were screened) and 28 cases (47 cases were screened) would be included in the first and second stages, respectively. If the number of patients with pCR in the first stage is less than 2, the study will be terminated. If the number of patients with pCR in the first stage is more than 2, a second-stage trial will be performed. If the total number of patients with pCR is more than 9, the effective remission rate of the RAIC regimen is considered to be acceptable.

Rectal Artery Infusion Chemotherapy Combined With Anti-PD1 Antibody for MSS LARC

Rectal Artery Infusion Chemotherapy of Oxaliplatin Plus Capecitabine Combined With Anti-PD1 Antibody After Induction Chemotherapy for Microsatellite Stable Locally Advanced Rectal Cancer：a Prospective Single-arm Phase II Study

the pathological complete remission rate of the rectal carcinoma

the rate of surgical complication during or after operation

Low anterior resection syndrome (LARS) score of different time during treatment. The range (0-42) was divided into 0 to 20 (no LARS), 21 to 29 (minor LARS), and 30 to 42 (major LARS).

Fms Related Receptor Tyrosine Kinase 3 Ligand is a marker of immunogenic cell death

blood density measurement of immunoreaction associated cytokines

blood density measurement of damage-associated molecular pattern（DAMP）

Second Affiliated Hospital, School of Medicine, Zhejiang University

Colonic Diseases

The patients receive primary rectectomy including anterior resection or abdominoperineal resection by open or laparoscopy with TME. To patients with pathological confirmed positive circumferential margin (CRM), postoperative concurrent radiochemotherapy is required that starts in 3 months post operation with capecitabine. Capecitabine and Oxaliplatin (CapeOx) chemotherapy starts in 4 weeks post operation to total of 6 cycles/18 weeks. To patients with pathological confirmed negative CRM, radiotherapy is omitted. The stage III patients receive 8 cycles/6 months CapeOx chemotherapy. The stage II patients with low microsatellite instability (MSI) receive 8 cycles/6 months Capecitabine chemotherapy. The stage II patients with high MSI and stage I patients do not receive adjuvant therapy.

All of the patients receive conventional concurrent radiochemotherapy with capecitabine for 5 weeks. Then all of the patients receive 2 cycles/6 weeks capecitabine ± Oxaliplatin chemotherapy. Patients receive rectectomy including anterior resection or abdominoperineal resection by open or laparoscopy with total mesorectal excision 8 weeks post radiotherapy. All of the patients receive 5 cycles/15 weeks capecitabine ± Oxaliplatin adjuvant chemotherapy. The use of Oxaliplatin depends on the doctor's decision.

45-50 Gy in 25-28 fractions to the pelvis. After 45 Gy a tumor bed boost with a 2 cm margin of 5.4 Gy in 3 fractions for preoperative cancers or 5.4-9.0 Gy in 3-5 fractions for postoperative cancers could be considered. Radiotherapy is used only for patients with pathological confirmed positive circumferential margin in Group primary surgery. Radiotherapy is used to all of the patients in Group preoperative radiochemotherapy.

Radiotherapy

Capecitabine 825 mg/m2 twice daily 5 or 7 days/week with concurrent radiotherapy in Group primary surgery and Group preoperative radiochemotherapy. Capecitabine 1250 mg/m2 twice daily 1-14 every 3 weeks to a total of 6 weeks after preoperative radiochemotherapy in Group preoperative radiochemotherapy. Capecitabine 1250 mg/m2 twice daily 1-14 every 3 weeks to a total of 6 months postoperative therapy for a part of stage II patients in Group of primary surgery. Capecitabine 1000 mg/m2 twice daily 1-14 every 3 weeks with oxaliplatin day 1 to a total of 6 months postoperative therapy for stage III patients in Group of primary surgery.

Oxaliplatin 130 mg/m2 over 2 hours, day 1, with capecitabine every 3 weeks. Repeat every 3 weeks to total of 6 months postoperative therapy.

Ke-Feng Ding, M.D.

The purpose of this study is to determine whether primary radiotherapy can be omitted for the locally advanced rectal cancer with Magnetic Resonance Imaging (MRI) negative circumferential margin.

The preoperative radiochemotherapy with fluorouracil followed surgery is the standard therapy for patients with locally advanced rectal cancer. However, the necessity of radiotherapy has been questioned for a long time especially for patients with enough circumferential margins. Moreover, indiscriminate radiotherapy will result Irreversible ovarian dysfunction for female. In the past decade, there were two major progresses for colorectal cancer. Firstly, oxaliplatin with fluorouracil has become the standard adjuvant chemotherapy for advanced colon cancer. Oxaliplatin improved the survival of colon cancer patients than single fluorouracil. Our experience showed that oxaliplatin with fluorouracil could improve the prognosis of rectal cancer without radiotherapy. It has been proven that oxaliplatin should not add to radiotherapy for rectal cancer. However, whether oxaliplatin can replace radiotherapy for certain rectal cancer patients is still unknown. Secondly, Magnetic Resonance Imaging (MRI) has been proven that can predict the circumferential margin status for rectal cancer. Now, preoperative MRI scan can recognize the rectal cancer patients with low recurrence risk. The radiotherapy may be omitted to the patients with low recurrence risk. This study is a randomized controlled trial to compare the 3-year disease-free survival (DFS) differences of group of experiment (the patients receive primary surgery followed selective radiochemotherapy) and group of control (the patients receive indiscriminate preoperative radiochemotherapy followed surgery) for locally advanced rectal cancer with negative MRI circumferential margin.

Randomized Trial of Primary Surgery Followed Selective Radiochemotherapy for Rectal Cancer With MRI Negative CRM

Randomized Trial of Primary Surgery Followed Selective Radiochemotherapy Versus Conventional Preoperative Radiochemotherapy for Locally Advanced Rectal Cancer With MRI Negative Circumferential Margin

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients	NCT00247338	Gastrointestina... Postoperative C...	low calorie, lo...	18 Years - 80 Years	Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
Rectal Artery Infusion Chemotherapy Combined With Anti-PD1 Antibody for MSS LARC	NCT05307198	Rectal Neoplasm...	Oxaliplatin Rectectomy Capecitabine Anti-PD-1 monoc...	18 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
The Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients	NCT00247338	Gastrointestina... Postoperative C...	low calorie, lo...	18 Years - 80 Years	Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
The Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients	NCT00247338	Gastrointestina... Postoperative C...	low calorie, lo...	18 Years - 80 Years	Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
Randomized Trial of Primary Surgery Followed Selective Radiochemotherapy for Rectal Cancer With MRI Negative CRM	NCT02121405	Colorectal Neop... Effects of Radi... Effects of Chem... Surgery	Rectectomy Radiotherapy Capecitabine Oxaliplatin	18 Years - 75 Years	Zhejiang University
Randomized Trial of Primary Surgery Followed Selective Radiochemotherapy for Rectal Cancer With MRI Negative CRM	NCT02121405	Colorectal Neop... Effects of Radi... Effects of Chem... Surgery	Rectectomy Radiotherapy Capecitabine Oxaliplatin	18 Years - 75 Years	Zhejiang University

Spots Global Cancer Trial Database for rectectomy

Every month we try and update this database with for rectectomy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rectectomy

Every month we try and update this database with for rectectomy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rectectomy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.