Stomach NeoplasmsPhase 2NCT06564298
A Study on the Combination of Sintilimab, Ramucirumab and Chemotherapy for First-line Treatment of Gastric Cancer With Liver Metastasis
A Phase 2 study testing Sintilimab, Ramucirumab and SOX/XELOX in people with Stomach Neoplasms, run by The First Affiliated Hospital with Nanjing Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Sintilimab, Ramucirumab and SOX/XELOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- Availability of representative tumor tissue specimens, blood samples, and fecal samples for exploratory research.
- Main organ functions must be normal, meeting the following criteria:
- Liver Function Alanine Aminotransferase (ALT) ≤5.0 × ULN Aspartate Aminotransferase (AST) ≤5.0 × ULN
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sintilimab Combined With Ramucirumab and Chemotherapy as First-line Treatment in Patients With Advanced Gastric Cancer With Liver Metastasis (RAMSINT): A Phase II, Single-center, Prospective Clinical Study
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?
Read more
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.
- Conditions
- Stomach Neoplasms
- Being tested
- Sintilimab, Ramucirumab, SOX/XELOX
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab 200mg iv.gtt d1, every 21 days
RamucirumabDrug
Ramucirumab 10mg/kg iv.gtt d1, every 21 days
SOX/XELOXDrug
SOX: Oxaliplatin 130mg/m2 iv.gtt d1, every 21 days and S-1 40mg/m2 po bid d1-14, every 21 days XELOX: Oxaliplatin 130mg/m2 iv.gtt d1, every 21 days and Capecitabine 1000mg/m2 po bid d1-14, every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab+Ramucirumab+SOX/XELOX | Experimental | Not described Receives: Drug: Sintilimab; Drug: Ramucirumab; Drug: SOX/XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR was defined as the proportion of participants whose tumor volume decreases to a predefined value and can maintain the minimum duration requirements, which is the sum of the rates of Complete Response (CR) and Partial Response (PR) according to RECIST 1.1 based on investigator assessment.
Measured: Up to approximately 12 months
Secondary outcomes (4)
Disease Control Rate (DCR)
DCR was defined as the percentage of the participants who achieve either a response (PR + CR) or Stable Disease (SD) after treatment and can maintain the minimum duration requirements according to RECIST 1.1 based on investigator assessment.
Measured: Up to approximately 12 months
Progression-free Survival (PFS)
PFS was defined as the time from the start of treatment to disease progression according to RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.
Measured: Up to approximately 16 months
Overall Survival (OS)
OS was defined as the time from enrollment to death due to any cause.
Measured: Up to approximately 16 months
Incidence of adverse events and serious adverse events (AEs)
Categorized according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0). Descriptive statistical analysis is primarily used to list and describe the AEs that occurred during this trial.
Measured: Up to approximately 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564298
- Sponsor's protocol ID
- 2024-SR-654
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Combined With Ramucirumab and Chemotherapy as First-line Treatment in Patients With Advanced Gastric Cancer With Liver Metastasis (RAMSINT): A Phase II, Single-center, Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06564298
- Acronym / sponsor ID
- 2024-SR-654
- Conditions
- Stomach Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab+Ramucirumab+SOX/XELOX | Experimental | Drug: Sintilimab, Drug: Ramucirumab, Drug: SOX/XELOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SintilimabSintilimab 200mg iv.gtt d1, every 21 days | Drug | Sintilimab+Ramucirumab+SOX/XELOX |
| RamucirumabRamucirumab 10mg/kg iv.gtt d1, every 21 days | Drug | Sintilimab+Ramucirumab+SOX/XELOX |
| SOX/XELOXSOX: Oxaliplatin 130mg/m2 iv.gtt d1, every 21 days and S-1 40mg/m2 po bid d1-14, every 21 days XELOX: Oxaliplatin 130mg/m2 iv.gtt d1, every 21 days and Capecitabine 1000mg/m2 po bid d1-14, every 21 days | Drug | Sintilimab+Ramucirumab+SOX/XELOX |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 12 months
ORR was defined as the proportion of participants whose tumor volume decreases to a predefined value and can maintain the minimum duration requirements, which is the sum of the rates of Complete Response (CR) and Partial Response (PR) according to RECIST 1.1 based on investigator assessment.
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to approximately 12 months
Progression-free Survival (PFS)
Time frame: Up to approximately 16 months
Overall Survival (OS)
Time frame: Up to approximately 16 months
Incidence of adverse events and serious adverse events (AEs)
Time frame: Up to approximately 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab, Ramucirumab and SOX/XELOX in people with Stomach Neoplasms, run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Wu (86-13913855335, whdactor@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.