View clinical trials related to Gastric Adenocarcinoma.
Filter by:The purpose of this study is to find a recommended schedule and dose range for Emibetuzumab when given with ramucirumab that may be safely given to participants with cancer. In Part A of this study, escalating doses of Emibetuzumab will be given in combination with a fixed dose of ramucirumab to evaluate the safety of the combination. After a recommended schedule and dose range of Emibetuzumab and ramucirumab has been established, Part B of the study will confirm safety and to see how well certain tumors respond to the combination of study drugs. The average amount of time on study is expected to be about 6 months.
A study to evaluate the safety and tolerability of DKN-01 in combination with weekly paclitaxel or pembrolizumab in participants with relapsed or refractory Esophagogastric Malignancies
Second-line chemotherapy represents an option in gastric cancer, especially for patients with adequate performance status. Two randomized phase III trials comparing 2nd-line docetaxel with best-supportive care have reported a benefit in favor of chemotherapy. Capecitabine is a fluoropyrimidine carbamate, which has a broader spectrum of antitumor activity than other fluoropyrimidines. In gastric cancer xenografts. metronomic capecitabine inhibited angiogenesis, growth of gastric cancer and improved survival with less toxicity. Given its potential low toxicity, the combination of docetaxel and metronomic capecitabine needs to be evaluated to assess efficacy and tolerability in patients with advanced gastric cancer previously treated with a fluoropyrimidine-based and platinum-based chemotherapy.
The study addresses two primary questions, according to its factorial design: - to compare the efficacy in terms of overall survival (OS) of a peri-operative vs. a post-operative chemotherapy (CHT) treatment, irrespectively of the presence of a post-surgical chemo-radiotherapy (CHT-RTX) (Timing Study); - to compare the efficacy in terms of relapse free survival (l-RFS) of a post-surgical CHT-RTX treatment vs. no other treatment, irrespectively of the timing of CHT (RTX Study). The study has a 2x2 factorial design, thus consisting of two independent, following specific eligibility criteria and with different randomization scheme studies, the Timing Study and the RTX Study. Both studies are Italian, multicentre, open-label, randomized, superiority, phase III trials conducted in patients with histologically confirmed, localized gastric adenocarcinoma, which is considered operable. In the Timing Study patients fulfilling the eligibility criteria will be randomized with a 1:1 ratio to receive: - peri-operative CHT (Arm A) or - post-operative CHT (Arm B) Once randomized in the Timing Study, patients may also be randomized in the RTX Study to receive in addition to CHT a post-operative CHT-RTX treatment or no other treatment. This is possible since the randomization will be done in two steps: the first for the Timing Study for all the participating centres (peri-operative CHT vs. post-operative CHT) and the second one for the RTX Study, only for those centres with the radiotherapist willing and able to participate (post- surgical CHT-RTX vs. no other treatment). Thus the following four arms will be generated: - peri-operative CHT (Arm A) - post-operative CHT (Arm B) - peri-operative CHT + post-operative CHT-RTX (Arm C) - post-operative CHT + post-operative CHT-RTX (Arm D) The study will be conducted in more than one hundred experimental centres. Follow-up F(-up) procedures and timing of the visits will be consistent with current clinical practice. Based on case-mix of sample 1000-1180 patients are needed in the Timing study and 420-520 in the RTX study.
Gastric or gastroesophageal junction adenocarcinoma is commonly treated with chemotherapy before and after surgery. The chemotherapy regimen used in our institution, called DCF (docetaxel,cisplatic, 5-fluorouracil) is active, resulting in tumor reduction and dysphagia relief. however, it is toxic, causing approximately half of patients severe inflammation of the mucosa (lining) of the mouth and gut. This results, in turn, in mouth sores, vomiting and diarrhea. Similar regimen called FLOT (5-FU, oxaliplatin,docetaxel) appears to be at least equally active, but less toxic. Our ultimate plan is to perform a randomized comparison of DCF and FLOT. Before embarking upon this, we are conducting this pilot trial in 10 subjects with the FLOT regimen. If less than 5 patients develop severe mouth sores, vomiting or diarrhea, plans will be made to proceed with the next trial, a randomized comparison of DCF and FLOT
A prospective, opened, multicentric, randomised, phase III trial with two arms: - Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin - Arm B: curative gastrectomy with D1-D2 lymph node dissection Main objective: Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone.
1. Target population:locally advanced gastric adenocarcinoma (LAGC, cT2~3/N+M0,or cT4aN+M0);no previous chemo or radio therapy. 2. Primary objective:Response rate of XELOX in the neoadjuvant setting of LAGC. Secondary objectives: - The progression free survival (PFS) in the perioperative treatment of locally advanced gastric adenocarcinoma (cT3/N+M0,or cT4aN+M0); - percentage of pathological response ; percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments; - D2 resection -rate after neoadjuvant chemotherapy of XELOX; - Overall survival; - QOL during the whole period of treatment. 3. Trial design:This is a multicenter, single arm, open-label, phase II study to evaluate the efficacy and safety of Oxaliplatin plus capecitabine(XELOX) in the perioperative treatment of locally advanced gastric adenocarcinoma in combination with D2 resection. 4. Treatment plan:Patients will be given the perioperative chemotherapy as below once recruited:Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow: Capecitabine 1000 mg/m2 ,bid,d 1~14 every 3 weeks(treatment for 2 weeks and rest 1 week)Oxaliplatin:130mg/m2, iv infusion over 2h,d1,every 3 weeks. 5. Number of subjects:50 patients.Number of centers 5 sites, which have the high volume of gastric operations in China, more than 500 per year.
Preoperative staging for gastric adenocarcinoma is an important procedure to detect advanced disease stateS for the patients in which the surgery may be unnecessary to perform. Although there are many imaging techniques for this purpose, sensitivity and specificity of these techniques still remains to be low.Preoperative detection of peritoneal carcinomatosis and involvement of lymph nodes beyond D2 may prevent surgical procedures. Removal of the determined lymph nodes according to the type of the surgery is the accepted surgical method. However, accurate determination of malignant lymph nodes may prevent dissection of some groups of the lymph nodes. These findings may cause a new definition of gastric lymph node dissection.
Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks, as is the standard administration dose and schedule. This application is a non-labeled indication for cabazitaxel and will inform future drug development in gastroesophageal malignancies, where docetaxel remains an approved first line agent, but is not routinely used due to excessive toxicity and marginal efficacy. At the conclusion of this study, we hope to demonstrate activity of single agent cabazitaxel in refractory gastric cancer, with preferential activity in one or more gastric cancer subtypes
Gastric cancer remains one of the major causes of cancer deaths around the world,especially in Asia. For advanced gastric cancer,even if treated with chemotherapy,the prognosis is still poor, so the investigators urgently need an effective strategy to treat advanced gastric cancer, however, there was no recommended First-line chemotherapy for advanced gastric cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound (Nab) Paclitaxel (Abraxane,ABI-007) with high effectiveness and low toxicity had been approved in breast cancer as first-line chemotherapy in many countries. The investigator then initiated a prospective phase II clinical trial with Nab-Paclitaxel plus Capecitabine as the first-line treatment in advanced gastric cancer to observe the efficacy and safety.