Combining ramucirumab with chemotherapy for advanced gastric cancer treatment
Evaluation of the Efficacy and Safety of Ramucirumab Combined With Nab-paclitaxel, Lobaplatin, and S-1 in Neoadjuvant and Conversion Therapy for Advanced Gastric Cancer (RNPLS-01)
PHASE4 · Xijing Hospital · NCT06169410
This study is testing whether combining a new drug called ramucirumab with chemotherapy can help people with advanced gastric cancer respond better to treatment.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Xijing Hospital (other) |
| Drugs / interventions | chemotherapy, immunotherapy, Ramucirumab |
| Locations | 1 site (Xi'an) |
| Trial ID | NCT06169410 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of ramucirumab combined with nab-paclitaxel, lobaplatin, and S-1 as a neoadjuvant therapy for patients with advanced gastric cancer. It is a prospective, single-center, randomized controlled trial involving 140 patients divided into two cohorts. The primary goal is to assess the pathological complete response (pCR) after treatment, while secondary outcomes include overall survival, progression-free survival, and the incidence of adverse events. The study aims to provide insights into improving treatment outcomes for advanced gastric cancer patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with locally advanced gastric or gastroesophageal junction adenocarcinoma requiring neoadjuvant therapy.
Not a fit: Patients who have previously received anti-tumor treatments or have severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could significantly improve the chances of complete cancer response and overall survival for patients with advanced gastric cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of therapies in treating advanced gastric cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Cohort A: Patients are diagnosed with locally advanced gastric or gastroesophageal junction adenocarcinoma by cytology or histopathology and in need of preoperative neoadjuvant therapy to reduce recurrence and metastasis rates; Cohort B: Patients with advanced gastric cancer who have undergone surgery after neoadjuvant chemotherapy with previously used nab-paclitaxel, lobaplatin and S-1. Patients are adults aged 18-75 years with an Eastern Cooperative Oncology Group(ECOG) performance status score less than or equals to 1. Have not received anti-tumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy) . Functions of the major organs and bone marrow meet the following criteria within 7 days before treatment: hemoglobin ≥ 80g/L, absolute neutrophil count ≥ 1.5 × 109/L, platelet (PLT) ≥ 100× 109/L, without blood transfusion within 14 days, total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5x ULN or if complicated with liver metastasis then ALT and AST ≤ 5x ULN, serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 50mL/min or urinary protein\<2+, activated partial thromboplastin time (APTT) and international standardized ratio (INR)≤1.5×ULN. Expected lifespan ≥ 6 months. The patients are able and willing to provide written informed consent to participate in the study. Exclusion Criteria: Patients who have previously suffered from other malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ. HER-2 positive patients who are willing to receive Herceptin treatment. Women who are pregnant or lactating or in the reproductive period and have not taken effective contraceptive measures, or those who have fertility requirements during the research period. Patients with serious and uncontrolled internal diseases and infections or with chronic bowel disease or short bowel syndrome. Patients with major organ failure, such as compensatory heart, lung, liver, and kidney failure as well as severe metabolic abnormalities in liver and kidney which affects normal drug metabolism. Patients with a clear tendency for gastrointestinal bleeding and/or abnormal coagulation function (INR\>1.5)under researchers evaluation. hepatitis B virus or hepatitis C virus in active phase Patients with peripheral neuropathy neoadjuvant chemotherapy(NCT)-CTCAE ≥ Level 2. -
Where this trial is running
Xi'an
- The First Affiliated Hospital of the Air Force Medical University — Xi'an, China (RECRUITING)
Study contacts
- Study coordinator: Jianjun Yang, professor
- Email: yangjj@fmmu.edu.cn
- Phone: 86+029-84771532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Gastric Cancer, Ramucirumab, nab-Paclitaxel, lobaplatin, S-1, advanced gastric cancer