A Study on the Combination of Sintilimab, Ramucirumab and Chemotherapy for First-line Treatment o… (NCT06564298) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study on the Combination of Sintilimab, Ramucirumab and Chemotherapy for First-line Treatment of Gastric Cancer With Liver Metastasis
39 participantsStarted 2024-08
Plain-language summary
The goal of this clinical trial is to observe the efficacy and safety of Sintilimab (a PD-1 inhibitor) combined with Ramucirumab (a VEGFR-2 antagonist) and chemotherapy as a first-line treatment for patients with advanced gastric cancer with liver metastasis.
* Can the combination of Sintilimab, Ramucirumab, and chemotherapy improve the prognosis of patients with AGC and liver metastases?
* What are the adverse events (AEs) associated with the use of the combination regimen of Sintilimab, Ramucirumab, and chemotherapy in patients with AGC and liver metastases?
Participants will:
* Receive a combined treatment regimen of Sintilimab, Ramucirumab, and chemotherapy (SOX (oxaliplatin and S-1) or XELOX (oxaliplatin and capecitabine)), administered every 21 days for up to 6 cycles. Following the completion of 6 cycles, maintenance therapy with Sintilimab and oral chemotherapy agents (capecitabine or S-1) with or without Ramucirumab will be administered until disease progression.
* Imaging assessments will be performed at baseline, after every 2 cycles of treatment, and every 3 months following the completion of 6 cycles of treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntary participation in the clinical study; full understanding and informed consent to this study by signing the Informed Consent Form (ICF); willingness to follow and ability to complete all trial procedures.
. Patients with histologically or cytologically confirmed, unresectable, or who refuse surgical resection of locally advanced, recurrent, or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma (including signet-ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma, etc.). (Note: For patients who relapse after neoadjuvant/adjuvant therapy, the time from the end of neoadjuvant/adjuvant therapy to disease relapse must be more than 6 months.)
. Patients, except those with recurrent disease after neoadjuvant/adjuvant therapy, must not have previously received systemic treatment.
. Participants must be histologically confirmed as having HER2-negative gastric cancer, GEJ cancer, or esophageal adenocarcinoma.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: Up to approximately 12 months
Trial details
NCT IDNCT06564298
SponsorThe First Affiliated Hospital with Nanjing Medical University
. There must be at least one measurable lesion in the liver assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) that can undergo repeat radiological evaluation; the radiological tumor assessment should be performed within 28 days prior to randomization.
. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2 within 7 days prior to the first dose of medication.
. Availability of representative tumor tissue specimens, blood samples, and fecal samples for exploratory research.
. Main organ functions must be normal, meeting the following criteria:
Exclusion criteria
. History of other active malignancies within the past 5 years or currently having other active malignancies. Treated localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, are eligible for inclusion.
. Underwent surgery within 4 weeks prior to the start of the study treatment.
. Known history of severe allergy to any monoclonal antibodies or excipients.
. Previous use of PD-1 inhibitors, LAG-3 inhibitors, CTLA-4 inhibitors, or any other antibodies or drug treatments targeting T-cell co-stimulation or immune checkpoint pathways, including previous receipt of anti-tumor vaccines or other immunostimulatory anti-tumor therapies.
. Previous exposure to VEGF (vascular endothelial growth factor) or VEGFR inhibitors or any anti-angiogenesis medications.