View clinical trials related to Gastric Cancer.
Filter by:The goal of this clinical trial is to compare the effectiveness of enhanced follow-up with standard follow-up in postoperative patients with advanced gastric cancer who have undergone radical gastrectomy. The main questions it aims to answer are: Can enhanced follow-up alleviate symptom burden and improve quality of life? What is the impact of enhanced follow-up on overall survival rates at 3 and 5 years post-surgery? Participants will: Be randomly assigned to either the enhanced follow-up group or the standard follow-up group. Undergo comprehensive symptom, nutritional, and psychological assessments every 3 weeks (enhanced follow-up group). Receive routine postoperative follow-up including medical examinations and treatments as needed, with additional assessments only when necessary (standard follow-up group). Researchers will compare the enhanced follow-up group with the standard follow-up group to see if enhanced follow-up can improve quality of life and increase overall survival rates at 3 and 5 years post-surgery. Outcomes will be measured using the EORTC QLQ-C30 quality of life questionnaire and overall survival rates. This prospective, single-center, randomized controlled clinical trial will span 5 years from the approval by the institutional ethics committee and will include 158 patients.
The objective of this trial is to compare the efficacy of a comprehensive treatment strategy involving PD-1 monoclonal antibody combined with XELOX chemotherapy followed by radical resection surgery, versus simple systemic treatment in patients with limited distant metastasis of gastric adenocarcinoma/gastroesophageal junction adenocarcinoma. After enrollment and successful screening, eligible participants will be randomized in a 1:1 ratio into a surgical arm and a non-surgical arm, and will undergo the following treatment: Surgical Arm: 1. Phase 1 Systemic Therapy: Administration of PD-1 monoclonal antibody in combination with XELOX chemotherapy for cycles 1-4. 2. Surgery: Performing a D2 standard gastrectomy for gastric cancer and radical resection of resectable metastatic lesions. 3. Phase 2 Systemic Therapy: Continuation of PD-1 monoclonal antibody combined with XELOX chemotherapy for cycles 5-8, followed by maintenance therapy with PD-1 monoclonal antibody and capecitabine monotherapy from the 9th cycle until two years post-enrollment. 4. During phase 2 systemic therapy, concurrent local treatments for unresected metastatic lesions are permitted, including radiotherapy, interventional embolization, radiofrequency ablation, and hyperthermic intraperitoneal chemotherapy (HIPEC). Non-Surgical Arm: 1. Phase 1 Systemic Therapy: Administration of PD-1 monoclonal antibody in combination with XELOX chemotherapy for cycles 1-4. 2. Phase 2 Systemic Therapy: Continuation of PD-1 monoclonal antibody combined with XELOX chemotherapy for cycles 5-8, followed by maintenance therapy with PD-1 monoclonal antibody and capecitabine monotherapy from the 9th cycle until two years post-enrollment.
Main Objective: To study the maximum tolerated dose (MTD) and dose-dependent toxicity (DLT) of cord blood-derived CAR-NK cells (CB CAR-NK182) targeting Claudin18.2 in patients with advanced gastric cancer and advanced pancreatic cancer. Secondary Objective: To evaluate the efficacy of CB CAR-NK182 in patients with advanced gastric cancer and advanced pancreatic cancer: overall objective tumor response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), etc. To evaluate the CAR-NK amplification and persistence of CB CAR-NK182 in the blood of patients with advanced gastric cancer and advanced pancreatic cancer;
Chemotherapy, immune checkpoint inhibitors, and anti-angiogenic targeted therapies have been explored in combination for neoadjuvant and conversion therapies. However, the efficacy of the novel anti-angiogenic agent fruquintinib in combination with immune checkpoint inhibitors and chemotherapy in the neoadjuvant and conversion treatment of locally advanced or metastatic gastric cancer has not been reported. This study aims to observe the efficacy and safety of fruquintinib combined with immune checkpoint inhibitors and chemotherapy in real-world settings.
This Phase II clinical study is a prospective, open-label, single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy (sintilimab) with thymosin α1 and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or esophagogastric junction (GEJ) adenocarcinoma. The primary objective is to explore the therapeutic efficacy and safety of this combined treatment approach. The secondary objective is to assess its impact on the tumor immune microenvironment in locally advanced gastric cancer. Study Design The study plans to enroll 30 patients who have been pathologically confirmed as HER2-negative and diagnosed with resectable stage III gastric or GEJ adenocarcinoma (Siewert type III and type II without the need for thoracotomy). The study includes multiple steps: Treatment Regimen: Participants will receive three cycles of sintilimab combined with the SOX regimen (oxaliplatin and S-1) and nine weeks of thymosin α1 before surgery. Assessment Points: Tumor response will be evaluated through imaging studies at the end of the second and third cycles of neoadjuvant therapy. Post-treatment surgery is scheduled within 2-6 weeks following the last dose of the third cycle. Pathological Evaluation: Surgical tumor samples will undergo pathological examination, including assessments for pathological complete response (pCR), tumor regression grade (TRG), major pathological response (MPR), overall response rate (ORR), disease control rate (DCR), clinical downstaging rate, and R0 resection rate. Safety Monitoring: Adverse events will be monitored throughout the treatment period to evaluate the safety of the neoadjuvant immunochemotherapy regimen. Follow-up: Patients will be followed up to calculate disease-free survival (DFS) and overall survival (OS). Eligibility Criteria Inclusion Criteria: i, Confirmed diagnosis of HER2-negative gastric or GEJ adenocarcinoma. ii. Clinical stage III, resectable tumors. iii. Adequate organ function and performance status. Exclusion Criteria: i. Prior treatment with immune checkpoint inhibitors. ii. History of autoimmune diseases or other malignancies. iii. Severe comorbidities that could interfere with the study. Goals and Objectives Primary Goal: To determine the effectiveness and safety of combining sintilimab with thymosin α1 and SOX as a neoadjuvant therapy. Secondary Goal: To investigate changes in the tumor immune microenvironment induced by the treatment and their correlation with therapeutic efficacy. Study Implications This study aims to provide critical insights into the potential benefits of integrating immunotherapy with chemotherapy and thymosin α1 in treating locally advanced gastric cancer. By focusing on both efficacy and immune microenvironment alterations, the findings could pave the way for novel neoadjuvant treatment strategies and improve clinical outcomes for gastric cancer patients.
This is a multicenter, randomized, open-label, phase 2 clinical study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of fruquintinib and chemotherapy (S-1 plus nab-paclitaxel) versus sintilimab and chemotherapy as conversion therapy in patients with stage IV gastric cancer in China.
For locally advanced gastric and gastroesophageal junction adenocarcinoma (cT3-4bNanyM0), perioperative PD-1 antibody combined with chemotherapy can downstage tumor stage, increase the R0 resection rate, and may improve the long-term survival. Combination of perioperative surufatinib, sintilimab and chemotherapy for locally advanced gastric and gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. Surufatinib, as the oral drug in this study is a small molecule kinase inhibitor that mainly acts on vascular growth factor receptor (VEGFR1, 2,3), fibroblast growth factor receptor 1(FGFR1) and colony stimulating factor 1 receptor (CSF1R). It is a proprietary product developed by Hutchison Whampoa Pharmaceutical (Shanghai, China) Co., LTD. Surufatinib has been approved for neuroendocrine tumor. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative surufatinib in combination with sintilimab and chemotherapy in locally advanced gastric and gastroesophageal junction adenocarcinoma.
This research constitutes a multi-centric, case-control designed investigation aimed at developing and implementing a blinded validation of a machine learning-powered, multi-cancer early detection model. This is to be achieved through the prospective collection of blood specimens from newly diagnosed cancer patients and individuals devoid of a confirmed cancer diagnosis
To evaluate the objective response rate (ORR) and disease control rate (DCR) of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer.
Recently, growing evidences have suggested that immunotherapy represents a promising treatment option for the neoadjuvant treatment of locally advanced mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) gastric cancer. In this study, we will explore the efficacy and safety of sintilimab and LDRT in the neoadjuvant treatment for locally advanced dMMR/MSI-H G/GEJ cancer.