Efficacy of Tirellizumab Combined With Oral, Intravenous and Abdominal Chemotherapy in Peritoneal Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Launched by FUDAN UNIVERSITY · Mar 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced gastric or gastroesophageal junction cancer that has spread to the lining of the abdomen, known as peritoneal metastasis. The researchers want to see if combining a medication called tirellizumab, which helps the immune system fight cancer, with chemotherapy and a specialized treatment called hyperthermic intraperitoneal chemotherapy (HIPEC) can improve outcomes for these patients. The goal is to shrink tumors, possibly allow for surgical removal, and ultimately improve survival rates.

To participate in this trial, patients must be between 18 and 75 years old and have a specific type of gastric cancer that has been confirmed through medical imaging and may have spread within the abdomen. They should not have received previous treatments for this cancer or have other significant health issues that could complicate their participation. Patients in the trial will receive the new treatment approach and be closely monitored for safety and effectiveness. This trial is important because it aims to explore a novel strategy that could potentially lead to better treatment options for those facing this challenging cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent Patients age 18-75 years Histologically CT/MRI confirmed cT3-4NanyM1 gastric or GEJ adenocarcinoma; Peritoneal metastasis was confirmed by laparoscopy (with or without Krukenberg tumor ) The degree of peritoneal metastasis ≤P1b or PCI≤13 points ECOG 0-1, no surgery contraindications; Expected survival ≥3 months;
• Exclusion Criteria:
• • Prior chemotherapy, radiotherapy, surgery for gastric cancer; Signs of other distant metastases (e.g., liver, lung, bone, supraclavicular lymph, etc.) Significant cardiovascular disease Major surgical procedure within 4 weeks prior to initiation of study treatment Current treatment with anti-viral therapy or HBV Pregnancy or breastfeeding History of malignancy within 5 years prior to screening Present or history of any autoimmune disease or immune deficiency Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors Poorly controlled hypertension or diabetes