A Study on the Combination of Sintilimab, Ramucirumab and Chemotherapy for First-line Treatment of Gastric Cancer With Liver Metastasis

Last updated: August 26, 2024
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Not Recruiting

Phase

2

Condition

Gastric Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

Ramucirumab

SOX/XELOX

Sintilimab

Clinical Study ID

NCT06564298
2024-SR-654
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntary participation in the clinical study; full understanding and informedconsent to this study by signing the Informed Consent Form (ICF); willingness tofollow and ability to complete all trial procedures.

  2. Patients with histologically or cytologically confirmed, unresectable, or who refusesurgical resection of locally advanced, recurrent, or metastatic gastric andgastroesophageal junction (GEJ) adenocarcinoma (including signet-ring cellcarcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma, etc.). (Note: Forpatients who relapse after neoadjuvant/adjuvant therapy, the time from the end ofneoadjuvant/adjuvant therapy to disease relapse must be more than 6 months.)

  3. Patients, except those with recurrent disease after neoadjuvant/adjuvant therapy,must not have previously received systemic treatment.

  4. Participants must be histologically confirmed as having HER2-negative gastriccancer, GEJ cancer, or esophageal adenocarcinoma.

  5. There must be at least one measurable lesion in the liver assessed by computedtomography (CT) scan or magnetic resonance imaging (MRI) according to the ResponseEvaluation Criteria in Solid Tumors (RECIST 1.1) that can undergo repeatradiological evaluation; the radiological tumor assessment should be performedwithin 28 days prior to randomization.

  6. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2within 7 days prior to the first dose of medication.

  7. Availability of representative tumor tissue specimens, blood samples, and fecalsamples for exploratory research.

  8. Main organ functions must be normal, meeting the following criteria:

Liver Function Alanine Aminotransferase (ALT) ≤5.0 × ULN Aspartate Aminotransferase (AST) ≤5.0 × ULN

Exclusion

Exclusion Criteria:

  1. History of other active malignancies within the past 5 years or currently havingother active malignancies. Treated localized tumors, such as basal cell carcinoma ofthe skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostatecarcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, areeligible for inclusion.

  2. Underwent surgery within 4 weeks prior to the start of the study treatment.

  3. Known history of severe allergy to any monoclonal antibodies or excipients.

  4. Previous use of PD-1 inhibitors, LAG-3 inhibitors, CTLA-4 inhibitors, or any otherantibodies or drug treatments targeting T-cell co-stimulation or immune checkpointpathways, including previous receipt of anti-tumor vaccines or otherimmunostimulatory anti-tumor therapies.

  5. Previous exposure to VEGF (vascular endothelial growth factor) or VEGFR inhibitorsor any anti-angiogenesis medications.

Study Design

Total Participants: 39
Treatment Group(s): 3
Primary Treatment: Ramucirumab
Phase: 2
Study Start date:
August 01, 2024
Estimated Completion Date:
June 30, 2026