To evaluate the efficacy and safety of Sintilimab in Combination With S-1/oxaliplatin With nab-paclitaxel intraperitoneal infusion as First-line Treatment for advanced gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma with malignant ascites
Peritoneal metastasis(PM) is common in advanced gastric cancer and associated with a poor prognosis. The efficacy of immunotherapy combined with chemotherapy in gastric cancer with PM is still not clear, and there is a lack of biomarkers for efficacy prediction. It is a single arm, open-label, phase II cinical trial conducted in China and plans to recruit 35 patients who were primarily diagnosed with unresectable or metastatic gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma with malignant ascites who have not received previous systemic treatment. Patients plan to receive sintilimab in combination with S-1/oxaliplatin with nab-paclitaxel intraperitoneal infusion as first-line treatment. The purpose of this study is to evaluate the efficacy and safety of sintilimab in combination with S-1/oxaliplatin with nab-paclitaxel intraperitoneal infusion for untreated advanced GC/GEJ adenocarcinoma with malignant ascites. To explore the potential biomarkers, tumor tissue paraffin section, peripheral blood, ascites, and feces before and after treatment will be collected and investigated by multiomics sequencing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Sintilimab: 200 mg, intravenous infusion, d1, q3w; Nab-paclitaxel: 100 mg/m2 intraperitoneal infusion, d1, q3w; S-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w; Oxaliplatin: 130 mg/m2, intravenous infusion, d1, q3w; The dosage can be adjusted according to the protocol according to the adverse reactions of subjects. Subjects wil 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.
Blood samples, tumor biopsy specimens, ascites, and feces samples will be collected at diferent time points (if feasible, according to the samples taken in the standard practice): at Baseline; After 1-2 cycles of treatment; at the time of the progression or recurrence, if applicable.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGAscites objective response rate (ORR)
The ascites objective response rate (ORR) was calculated as a summed ratio of patients with disappeared and decreased ascites to the total number of patients.
Time frame: 1 year
Overall Survival (OS)
OS is calculated from diagnosis to death or last follow-up time
Time frame: 1 year
Progress free survival (PFS)
PFS is defined as the time from the date of treatment to the first date of disease
Time frame: 1 year
12 months os rate
The definition of 12-months OS rate is the percentage of patients who had NOT has an event before or at 12 months
Time frame: 1 year
Obiective response rate of Solid tumor lesion (if exists)
Number of participants with partial response or complete response treating by anloitnib according to RESIST criteria v1.1
Time frame: 1 year
Safety assessment
Number and percentage of participants with Adverse Events (any Grade and Grade 3/4)
Time frame: 1 year
Changes of ascite cell subsets in patients
Changes in ascites cell subsets in patients before and after treatment. Differences in the proportion of subpopulations and gene expression levels of ascites cells between responders and non-responders by single-cell sequencing.
Time frame: 1 year
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