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

Sponsor
Zhongshan Hospital Xiamen University
Study ID
NCT05441254
Phase
PHASE2
Status
Unknown

Conditions

  • Stage IV Gastric Cancer With Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab; Nab-paclitaxel; S-1 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2022
Status verified
Jul 2022
Primary completion
Jun 30, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    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;

Primary Outcome Measure

Progression Free Survival(PFS) [ Time Frame: 24 months ]

Central Contacts