Active clinical trials for "Stomach Neoplasms"

This is a phase II study to evaluate the efficacy and safety of combination of fruquintinib (VEGFR 1/2/3 inhibitor), sintilimab (PD-1 inhibitor) and SOX conversion therapy in unresectable advanced gastric cancer patients.

Gastric cancer is the fifth most common carcinoma in the world, and cancer-related deaths rank third. It is one of the main causes of death from cancer in Korea. The cure method for gastric cancer is radical resection, but in most patients, radical resection is impossible due to local infiltration or peripheral organ or distant metastasis. Many assisted chemotherapy has been studied to improve survival rate, and in East Asia, assisted chemotherapy after complete D2 resection is the standard treatment. In the West, on the other hand, preoperative chemotherapy and postoperative assisted chemotherapy are currently standard treatments. However, due to the limited effect of adjuvant chemotherapy, it has been reported that better clinical course can be improved by increasing anticancer intensity. In this context, a large number of prior chemotherapy have been attempted, and prior chemotherapy has several potential effects as follows. (1) Improvement of R0 resection rate due to reduced primary cancer size, (2) early treatment for micro metastasis, (3) evaluation of treatment response rate in patients with measurable lesions, and (4) unnecessary laparotomy can be avoided in patients with biologically aggressive diseases. Based on the efficacy of chemotherapy in the combination of docetaxel, fluoropyrimidine, and platinum in metastatic gastric cancer, the investigators conducted a preceding auxiliary anti-cancer clinical trial of docetaxel, capecitabine and cisplatin in advanced gastric cancer patients who could not be completely resected by surgery. DXP was performed 4-6 cycles before surgery with the recommended dose in phase 1-2. In a total of 49 patients, R0 resection was performed in 31 (63%), and among patients, R0 resection was improved in cases where resection was not possible due to local infiltration (71%) and in cases where para-aortic node metastasis was performed (73%). We have reported that docetaxel, oxaliplatin, and S-1 chemotherapy (DOS) as preoperative adjuvant therapy can be safely administered in combination with D2 gastrectomy and postoperative adjuvant therapy S-1 in potentially resectable local progressive gastric cancer patients. R0 resection was achieved in 97.6% of patients, and pathological complete remission was observed in 19.5%. Based on this, a phase 3 PRODIGY study was performed to evaluate the benefit of S-1 (CSC group) as a preoperative prior chemotherapy compared to S-1 (SC group) as a postoperative adjuvant therapy in gastric cancer of cT2/3N+ or cT4Nany stage, and 0.75% of the CSC group was administered HR. In the patient group undergoing surgery, the R0 resection rate was 95% in the CSC group and 84% in the SC group. In the CSC group, the pathological complete remission rate was 10.4%. Based on these results, a clinical trial of DOS as a preoperative chemotherapy was planned for progressive gastric cancer that could not be resected due to local progression or metastasis limited to remote lymph nodes. Primary goal: Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial. Secondary objective: safety evaluation, overall survival period, progression-free survival period, pathological complete remission rate, and investigation of biological markers.

This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA neoantigen tumor vaccine in the treatment of advanced gastric cancer, esophageal cancer, and liver cancer, including two phases: dose escalation and dose expansion. To evaluate the safety and tolerability of neoantigen tumor vaccine in subjects with advanced gastric cancer, esophageal cancer and liver cancer by conducting dose escalation trial in subjects diagnosed with advanced gastric cancer, esophageal cancer and liver cancer, and preliminarily evaluate the efficacy of neoantigen tumor vaccine in subjects with advanced gastric cancer, esophageal cancer and liver cancer. According to the characteristics of safety and efficacy data in the dose escalation phase, the dose expansion is performed at the intended clinical dose based on the investigator's judgment, and the treatment is performed in combination with PD-1/L1 to further evaluate the efficacy and safety profile of neoantigen tumor vaccine at a specific dose. Both the dose escalation phase and dose expansion phase include a screening period (Week -4 ~ Week -2), a baseline period (Week -1 ~ Day -1), a treatment period (Day 1 ~ Week 8 or 16), and a follow-up period. Subjects who signed and provided the formal informed consent entered the screening period. The treatment period included the initial treatment period (Day 1 ~ Week 8) and the enhanced treatment period (Week 12 ~ Week 16). The investigator determined whether to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors from Week 8 to Week 12. The dose escalation phase follows standard 3+3 design. 12-18 subjects are expected to be enrolled at 3 given dose level. The investigator will choose the optimal clinical dose for dose expansion, which can be one dose group or multiple dose groups. PD-1/L1 drugs are used in parallel to further confirm the efficacy and safety of neoantigen tumor vaccine, with about 18 subjects. The usage and dosage of PD-1/L1 should aligned with the package insert.

This study will evaluate the safety efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive solid tumors and in combination with pembrolizumab in patients with recurrent/metastatic nasopharyngeal carcinoma

According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety, or affect the patient's completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.);

The goal of this clinical trial is to study the safety and efficacy of lenvatinib combined with single-agent taxanes therapy in patients with HER2-negative advanced gastric cancer that have failed at the standard first-line therapy.

To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.

Patients with histologically confirmed gastric adenocarcinoma with locally advanced gastric cancer are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy or neoadjuvant chemotherapy alone using XELOX regimen following D2 gastrectomy and adjuvant chemotherapy for 3 cycles. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety.

multicenter, open label, randomaized, phase III The role of post surgery adjuvant chemotherapy is becoming more and more important in AGC (advance gastric cancer). S-1 and combined therapy of Capecitabine and Oxaliplatin are currently accepted as a standard therapy among the AGC patients who were performed gastrectomy from the D2 surgery. However, many improvements will be needed in stage IIIB and IV. Combined chemotherapy of Docetaxel, Capecitabine, and Oxaliplatin may be considered as one of the best treatments for IIB and IV(M0) stage AGC patients who were performed gastrectomy.

For patients who failed primary chemotherapy with MET amplification, The efficacy and safety of the chemotherapy are evaluated by using dervalumab and saboritinib in combination.