Using Serplulimab with chemotherapy for advanced stomach cancer treatment

Neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer: a Single-arm Phase 2 Trial

This study is testing whether adding a new immunotherapy drug called Serplulimab to chemotherapy can help shrink tumors in patients with advanced stomach cancer before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: radiation, prednisone, Serplulimab, Chemotherapy
• Locations: 1 site (Tianjin)
• Trial ID: NCT06496789 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Serplulimab, an immunotherapy drug, in combination with chemotherapy for patients with locally advanced gastric or gastro-esophageal junction cancer. The study focuses on patients who are clinically diagnosed with resectable stage T3-4aN+M0 adenocarcinoma. Participants will receive the treatment prior to surgery to assess how well it works in shrinking tumors. The trial aims to improve outcomes for patients undergoing surgical intervention for this type of cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed resectable gastric or gastro-esophageal junction adenocarcinoma.

Not a fit: Patients with serious concomitant diseases or those whose cancer is not resectable may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance the effectiveness of surgery and improve survival rates for patients with advanced gastric cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in treating gastric cancer, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* histologically documented adenocarcinoma of Gastric or Gastroesophageal Junction. 2. clinically diagnosed stage T3-4aN+M0 according to ultrasound endoscopy or enhanced CT/MRI scan. 3. Male or female. Age ≥ 18 years and ≤75 years. 4. surgeons participating in this study consider the lesion a resectable one. 5. ECOG 0\~1 6. Physical condition and adequate organ function to ensure the success of abdominal surgery. 7. Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L. 8. Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \< 2.5 × ULN . ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L. 9. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min. 10. Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN. 11. No serious concomitant disease that will threaten the survival of patients to less than 5 years. 12. Written (signed) informed consent. 13. Good compliance with the study procedures, including lab and auxiliary examination and treatment. 14. Female patients should not be pregnant or breast feeding. 15. PD-L1 assessment

Exclusion Criteria:

* patients with distant metastasis or unresectable primary lesion. 2. patients with T1, T2 lesion according to CT/MRI or ultrasound endoscopy. 3. history of chemo, radiation, immune therapy or radical resection for the GC/GEJ. 4. patients with active autoimmune disease or history of refractory autoimmune disease. 5. patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured locally tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ. 6. uncontrollable pleural effusion, pericardial effusion, or ascites in 2 weeks before recruitment. 7. patients who have digestive tract bleeding in 2 weeks before recruitment or with high risk of bleeding. 8. perforation / fistula of GI tract in 6 months before recruitment. 9. patients with upper GI tract obstruction or functional abnormality or malabsorption syndrome, which can affect absorption of S-1. 10. losing over 20% body weight in 2 months before recruitment. 11. pulmonary disease history: interstitial pulmonary disease, non-infective pneumonitis, pulmonary fibrosis, acute pulmonary disease. 12. uncontrollable systemic diseases, including diabetes, hypertension, etc. 13. severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB or HIV, etc. 14. patients with untreated chronic hepatitis B or HBV DNA over 500 IU/ml or positive HCV RNA. 15. patients with any cardiovascular risk factors below:

  1. cardiac chest pain occurring in 28 days before recruitment, defined as moderate pain that limits daily activity.
  2. pulmonary embolism with symptoms occurring in 28 days before recruitment.
  3. acute myocardial infarction occurring in 6 months before recruitment.
  4. any history of heart failure reaching grade 3/4 of NYHA in 6 months before recruitment.
  5. ventricular arrhythmias of Grade 2 or grater in 6 months before recruitment, or accompanied by supraventricular tachyarrhythmias requiring medical treatment.
  6. cerebrovascular accident within 6 months before recruitment. 16. patients with peripheral neuropathy NCI CTC AE grade 1, except those with only deep tendon reflex disappearing. 17. moderate or severe renal injury \[creatinine clearance rate≤50 ml/min (according to Cockroft \& Gault equation)\], or Scr\>1.5 x ULN. 18. dipyrimidine dehydrogenase (DPD) deficiency. 19. allergic to any drug in this study. 20. history of allogeneic stem cell transplantation or organ transplantation. 21. use of steroids (dosage\>10mg/d prednisone) or other systemic immune suppressive therapy in 14 days before recruitment, except patients treated with regimens below: a. steroids for hormone replacement (dosage\>10mg/d prednisone); b. steroids for local application with little systemic absorption; c. short -term (≤ 7 days) steroids for preventing allergy or vomiting. 22. vaccinated with live vaccine in 4 weeks before recruitment. 23. receiving immune (interleukin, interferon, thymin) treatment or treatment of other trials in 28 days before recruitment. 24. receiving palliative radiation in 14 days before recruitment. 25. history of anti PD-1, PD-L1, PD-L2 or any other specific T cell costimulation or checkpoint pathway targeted treatment. 26. receiving operation in 28 days before recruitment, only if the operation is a minimally invasive one e.g. PICC. 27. for patients with uncontrolled epilepsy, CNS diseases or history of mental disorder, researchers should evaluate whether their diseases will impede their signing of informed consent or compliance of treatment.

Where this trial is running

Tianjin

• Tianjin Medical University Cancer Institute & Hospital — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: hongjie zhan

Conditions Gastric Adenocarcinoma