SOX Combined With Sintilimab and Trastuzumab Versus SOX Regimen in the Perioperative Treatment of HER2-positive Locally Advanced Gastric Adenocarcinoma

Launched by AIPING ZHOU · Jan 28, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with HER2-positive locally advanced gastric cancer. The researchers want to see if combining a chemotherapy regimen called SOX (which includes two drugs: S-1 and oxaliplatin) with two targeted therapies, sintilimab and trastuzumab, can improve treatment outcomes compared to using the SOX regimen alone. The goal is to enhance the effectiveness of the treatment before surgery, potentially leading to better recovery and outcomes for patients.

To be eligible for this trial, participants need to be between 18 and 75 years old and have a specific type of stomach cancer confirmed by medical tests. They should not have received any prior chemotherapy, immunotherapy, or radiation treatment. Additionally, candidates must have good overall health and organ function as assessed by their doctor. If someone joins the trial, they can expect to receive the study medication, monitor their health closely, and contribute to important research that could help improve treatment for future patients. This trial is still in the planning stages and is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Sign the informed consent form.
• • Locally advanced adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II/III) confirmed by pathology or cytology.
• • The definition of a positive HER2 test result is as follows: IHC detects HER2 3+ or IHC detects HER2 2+ and FISH is positive.
• • Clinically, based on chest, abdomen and pelvic CT, gastroscopy, endoscopic ultrasonography, gastrointestinal contrast, ordinary ultrasound, or laparoscopy if possible, it is judged as T3-4a N+ or T4bN any gastric cancer or gastroesophageal junction cancer (refer to AJCC Article Version 8 in stages).
• • Patients have not received chemotherapy and/or immunotherapy and/or trastuzumab treatment and/or radiotherapy in the past.
• • Age 18-75 years old.
• • The Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1, and there was no deterioration within 2 weeks before the first administration of the study drug.
• * Good organ function:
• • Blood routine: hemoglobin ≥90g/L, white blood cell ≥3.0×109/L, neutrophil ≥1.5×109/L, platelet ≥100×109/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥60ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL.
• Exclusion Criteria:
• • The pathology is other types besides adenocarcinoma, such as squamous cell carcinoma, adenosquamous carcinoma, neuroendocrine carcinoma and so on.
• • Have received chemotherapy and/or radiotherapy in the past.
• • Have received any anti-PD-1, anti-PD-L1/L2 antibodies, anti-CTLA-4 antibodies and other immunotherapy in the past.
• • Have received any anti-HER2 therapy in the past.
• • Intra-abdominal dissemination or distant metastasis (M1).
• • Clinically significant ascites.
• • Known to have allergic reactions to oxaliplatin and any ingredients or excipients of Tiggio.
• • Known to have allergic reactions to any ingredients or excipients of Sintilimab and Trastuzumab.
• • Inability to swallow, intestinal obstruction, or other factors that affect the administration and absorption of the drug.