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Exploratory clinical study of cindilimab combined with S-1 oral plus paclitaxel injection intravenous and intraperitoneal infusion chemotherapy in the treatment of peritoneal metastasis and transformation of gastric cancer

Exploratory clinical study of cindilimab combined with S-1 oral plus paclitaxel injection intravenous and intraperitoneal infusion chemotherapy in the treatment of peritoneal metastasis and transformation of gastric cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052478
Enrollment
Unknown
Registered
2021-10-28
Start date
2021-10-27
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Test group 1:Paclitaxel injection intraperitoneal perfusion plus intravenous chemotherapy + S-1 oral + Intravenous infusion of cindilimab injection

Sponsors

Affiliated Cancer Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged 18 to 75 years; 3. Adenocarcinoma of stomach and gastroesophageal junction confirmed by histopathological examination; 4. Diagnosed with gastric cancer and staging by laparoscopy, diagnosed with peritoneal metastasis and/or positive ascites peritoneal lavage fluid (P1 and/or CY1)), and has not received anti-tumor therapy (radiotherapy, chemotherapy, targeted or immunotherapy, etc.) ;PCI (peritoneal cancer index) 3 months; 9. Adequate organ function.

Exclusion criteria

Exclusion criteria: 1. Her-2 test is positive; 2. Known to show signs of active bleeding in the lesion under endoscopy, and have a history of gastrointestinal perforation and/or fistula within 6 months; 3. Diagnosed with malignant diseases other than gastric cancer within 5 years before the first administration (excluding basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 4. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose.

Design outcomes

Primary

MeasureTime frame
R0 resection rate;Conversion rate of operation;

Secondary

MeasureTime frame
Incidence of complications;Adverse reactions of immunotherapy;rate of main pathological remission;

Countries

China

Contacts

Public ContactLiu Kai

Affiliated Cancer Hospital of Shandong First Medical University

954947157@qq.com+86 13954117480

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026