About this trial
In this phase 2 study, we combined Cadonilimab, LM-302, and S-1 combined with intraperitoneal infusion of paclitaxel as regimen to treat gastric cancer patients with peritoneal metastasis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed gastric adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;
Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy, and without gastric outflow tract obstruction and intestinal obstruction; Written (signed) informed consent;
Claudin 18.2 positive (≥ 25%, and the proportion of positive cells greater than 50% of the cases accounted for not less than 70%);
Age ≥ 18 years at registration;
Disqualifiers
Confirmed of evidence of distant metastasis other than peritoneal metastasis (e.g.liver metastasis, lung metastasis, para-aortic lymph node metastasis, etc.);
During pregnancy, within 28 days of post parturition, or during lactation;
Previously received immunotherapy such as PD-1/PD-L1 and CTLA-4 or targeted therapy such as Claudin 18.2.
Synchronous or metachronous (within 5 years) malignancies.
Trial design
Single group
Treatments tested in this trial
Cadonilimab, LM-302, S-1, paclitaxel
DrugCadonilimab 10mg/kg, LM-302 2.0mg/kg intravenous (IV) infusion on day 1, paclitaxel 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1 80 mg/m2 for 14 consecutive days every 3 weeks.
Treatment groups
Trial outcomes
Primary outcomes
1-year survival rate
Secondary outcomes
treatment related adverse events
Objective response rate
pCR rate after conversion surgery
Duration of Response
Duration of Response
Sponsors and contacts
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