NCT05441254

Camrelizumab Combined With Intraperitoneal Infusion of Nab-paclitaxel, Intravenous Chemotherapy and S-1 in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis：Single-arm, Prospective Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Zhongshan Hospital Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people.

Detailed description

The incidence of gastric cancer in China is high. Although the guidelines have recommended standard first and second-line chemotherapy, the survival rate of patients with advanced gastric cancer with peritoneal metastasis is still low.Nab-paclitaxel is a taxane drug, because of its binding to albumin, it does not need pretreatment before infusion, which is convenient for infusion, and has great application prospects in the treatment of advanced gastric cancer. There are positive expectations regarding the safety and efficacy of the combination. With the deepening of the understanding of the body's immune system and the rapid development of biotechnology, immunotherapy has become an important means of tumor treatment, and occupies an increasingly important position in the comprehensive tumor treatment system. At the same time, a number of studies have confirmed that camrelizumab combined with chemotherapy has a better therapeutic effect in gastric cancer, and the safety is tolerable. In summary, how to improve the short-term and long-term efficacy of gastric cancer with peritoneal metastasis, while improving patient tolerance as much as possible and reducing adverse reactions, is an urgent problem to be solved. The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people.

Conditions

• Stage IV Gastric Cancer With Metastasis

Interventions

Type	Name	Description
DRUG	Camrelizumab; Nab-paclitaxel; S-1	Camrelizumab: 200 mg, intravenous infusion, d1, q3w; Nab-paclitaxel: 130 mg/m2 intraperitoneal and 130 mg/m2 intravenously, d1, q3w; S-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w; The dosage can be adjusted according to the protocol according to the adverse reactions of subjects. Subjects will continue to take medication until completion of the prescribed course of treatment, disease progression, toxicity intolerance, withdrawal of Informed Consent Form, or termination in the investigator's judgment.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2022-07-01
• Last updated: 2022-07-08