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GV1001 combination therapy in metastatic colorectal cancer

ABSTRACT: Interventions: Drug : Study design &Intervention schedule This study is a multicenter, phase 2, single arm study. Individual investigators are allowed to choose 2nd line chemotherapy agents,bevacizumab, cetuximab,aflibercept depending on their decision. GVl001 is injected intradermally on days 1, 3, 5 and 8 of the first cycle of 2nd line chemotherapy with a dose of 0.56 mg, and then injected on day 1 of subsequent chemotherapy. GV1001 should be injected intradermally in the lower abdomen with 0.2 mL of diluted to 0.30 mL of 0.9% normal saline (2.8 mg/mL), administered immediately after dilution (at least within 6 hours after dilution). This treatment is repeated every 2 weeks until the discontinuation of treatment due to the patients’ request, the toxicity, or the progress of the disease. Primary outcome(s): Disease control rate

DISEASE(S): Neoplasms

PROVIDER: 2511784 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background: Acute diarrhea is still a common and serious disease. The causes of acute diarrhea are very complicated. Therefore, we need to find a medicine to control diarrhea symptoms, save time for diagnosis of pathogens, and prevent drug abuse. Ellagic acid (EA), a natural polyphenol drug, has anti-diarrhea effects. However, the action mechanisms of EA for non-specific diarrhea have not been characterized. Materials and methods: To study the mechanisms of EA, mice were divided into four groups (group C were intraperitoneally injected with 0.1 ml physiological saline and orally given 0.2 ml physiological saline, and then after experiment began 0.5 h, orally administered 0.3 ml physiological saline. Group D were intraperitoneally injected with 0.1 ml physiological saline and orally given 0.2 ml castor oil, and then after experiment began 0.5 h, orally administered 0.3 ml physiological saline. Group E were intraperitoneally injected with 0.1 ml physiological saline and orally given 0.2 ml castor oil, and then after experiment began 0.5 h, orally administered 0.3 ml EA (10 mg/ml). Group V were intraperitoneally injected with 0.1ml GW9662 (1m g/ml) and orally given 0.2 ml castor oil, and then after experiment began 0.5 h, orally administered 0.3 ml EA (10 mg/ml).) Transcriptome were performed on ileum tissues of mice in group D and E. Histological examination and qRT-PCR were performed on ileum tissues of mice in group C, D, E and V. Results: We found that a total of 273 differentially expressed genes (DEGs) were obtained, including 160 up-regulated DEGs and 113 down-regulated DEGs. The DEGs were enriched in 458 Gene Ontology (GO) terms and 15 Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways, respectively. The peroxisome proliferator activated receptor (PPAR) signaling pathway was the most significantly enriched in KEGG pathways. We used the PPAR-specific antagonist GW9662 to validate the anti-diarrhea and anti-inflammatory effect of EA in group V compared with group E. Conclusively, EA protected ileums against castor oil-induced inflammation and diarrhea by activating the PPAR signaling pathway and a method was used to study the mechanism of EA.

Project description:Interventions: Onco-specific treatment: -Surgical treatment in resectable tumors (liver, lung), followed by first-line systemic chemotherapy four weeks later. -First-line systemic chemotherapy in non-resectable tumors. First-line chemotherapy: Six cycles every 4 weeks of: - Leucovorine (folinic acid) 20 mg/ m2/ daily, intravenously, for 5 days. Leucovorine will be administered after dilution in 50 cc of a 0.9% sodium chloride solution, intravenously, 20 minutes before 5-FU. - 5-Fluoracyl (5-FU): 375 mg/ m2/ daily, intravenously, for 5 days. The 5-FU will be administered either in a 5% dextrose solution or a 0.9% sodium chloride solution, 500 cc in 24 hour continuous infusion. Schemes containing Oxaliplatino, Irinotecan or a similar drug authorized for this purpose can also be used in combination with those nationally and internationally authorized and regulated. In conjunction with chemotherapy, the following can be administered: - 100 mg Dimenhydrate, either intravenously or in the chemotherapy infusion flask. - 20 mg Metoclopramide, either intravenously or in the chemotherapy infusion flask. Vaccine preparation: Patients will be administered a total of 15 vaccines, beginning 4 weeks after latest onco-specific treatment. The first 5 vaccines will be administered at 14 day intervals, and the other 10 every month until reaching one year immunization. Each vaccine will contain 1 ml of the vaccine preparation, at a 2 mg/ ml concentration of the 1E10 antibody. The total dose will be subdivided into 4 equal sub-doses, administering 250 µl (0.25 ml) at each inoculation site. The 1E10 anti-idiotype vaccine will be intradermally injected. The potential immunization sites are: deltoid region, anterior surface of forearm, provided that no resection has been performed, and posteri;Leucovorin;Fluorouracil;Vaccines ;Antibodies, Anti-Idiotypic;Antibodies ;Surgical Procedures, Operative;Antineoplastic Combined Chemotherapy Protocols;Infusions, Intravenous;Injections, Intradermal;Oxaliplatino Irinotecan 1E10 anti-idiotype vaccine Primary outcome(s): Survival time. Measuring time: 16 months Study Design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment

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GV1001 combination therapy in metastatic colorectal cancer

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