This trial is evaluating whether TJ004309 will improve 1 primary outcome and 13 secondary outcomes in patients with Gastrointestinal Cancers. Measurement will happen over the course of Up to 120 weeks.
This trial requires 60 total participants across 1 different treatment group
This trial involves a single treatment. TJ004309 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
"There were substantial improvements in survivorship of gastrointestinal cancer patients since the introduction of chemotherapy in the 1960s. These improvements have resulted in more cancer patients being cured of gastrointestinal cancers such as colorectal cancer. The proportion of people who have been cured of cancer by the end of life, however, is still very low and highlights the need for improvement in cancer survivorship interventions and the development of new cancer medications." - Anonymous Online Contributor
"The five most common gastrointestinal cancers can present with pain, a change in appearance or weight, itching, gastrointestinal bleeding or a change in bowel habits (either constipation or diarrhoea). Pain in colorectal cancer may be accompanied by perineal swelling. Bleeding from gastrointestinal cancers may occur anywhere within the gastrointestinal tract, including the oesophagus, stomach, duodenum, colon, rectum, liver, bile ducts etc. The presence of haemorrhoids and melena in association with abdominal pain in the setting of gastrointestinal cancer must prompt further investigation as to the presence of oesophageal or gastric cancer." - Anonymous Online Contributor
"Common treatment strategies include surgery (laparotomy or laparoscopy), chemotherapy, radiation, targeted therapy, or a combination of these therapies. The role for biopsy remains unclear. It may be indicated for certain histology types." - Anonymous Online Contributor
"Approximately 41,000 people develop [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) each year in the United States. Of these, over 30,000 develop adenocarcinoma. At 10 years from diagnosis, the cancer-specific survival is 80%. By age 65, however, this declines to 62%." - Anonymous Online Contributor
"Gastrointestinal cancers occur as a result of multiple etiologies. Risk factors such as smoking, alcohol use, obesity, and infectious diseases all contribute to gastrointestinal cancer etiology." - Anonymous Online Contributor
"GICs are the leading cause of deaths due to cancer in the developed world. They have become the leading cause of cancer deaths in low-middle income countries. A more aggressive approach to prevention and cure is essential." - Anonymous Online Contributor
"Risk factors for colorectal cancer and gastric cancer were similar. The primary cause of gastric cancers is not clear. However, it is hypothesized that chronic inflammation from NSAIDs or alcohol may contribute to gastric cancers. This suggests that gastric cancers are more likely to occur later in adulthood. The primary cause of colorectal cancers is not clear. However, the primary cause of rectal and colon cancers is most likely to be dietary factors. Higher fiber intake, particularly dietary fiber from vegetables, and high fiber dietary supplements, may help reduce the risks of colorectal cancer." - Anonymous Online Contributor
"There is a substantial age range at which GI cancers are diagnosed, highlighting the need for tailored care for younger and older patients. Better understanding cancer surveillance and risk factors needs to be developed, especially for older patients considering surgical intervention." - Anonymous Online Contributor
"After 6 months of treatment (maximum 6 months), the commonest side effects were abdominal pain (3.1%), constipation (2.5%), diarrhea (2.0%), fatigue (2.0%), vomiting (1.3%), nausea (1.0%), loss of appetite (1.0%), increased cholesterol (1.0%). There were three cases of liver function test abnormalities. Three patients suffered severe nausea, vomited and/or had diarrhea when the dose was increased. There were no patients who exhibited a decrease of treatment dose." - Anonymous Online Contributor
"The data indicate that Tj004309 is an effective chemopreventive agent after it has already been established that it can inhibit the development of new pancreatic intraepithelial neoplasia." - Anonymous Online Contributor
"Overall, survival from the time of diagnosis of gastrointestinal cancers improved in the time period of 1987-1996, to the years thereafter. There was significant variation among sites of primary, but not secondary, cancer with some sites of gastrointestinal cancers having improved survival while others had worse survival. Survival was worse in men from all sites of cancer, especially those diagnosed with gastric cancer." - Anonymous Online Contributor
"The prognosis of the gastrointestinal cancers was poor. Although conventional chemotherapy had a benefit against several types of gastrointestinal cancers, the majority of the patients died because of recurrent or metastatic gastrointestinal cancers despite treatment with drugs such as methotrexate, 5-fluorouracil, capecitabine, cyclophosphamide, streptozotocin, irinotecan, oxaliplatin, 5-fluorouracil-cobalamin-E2, fluorouracil, and leucovorin." - Anonymous Online Contributor