Efficacy and Safety of Camrelizumab in Combination With Apatinib Mesylate, Paclitaxel-albumin and S-1 for Translational Treatment of Gastric Cancer

Beijing Friendship Hospital1 site in 1 country30 target enrollmentMarch 1, 2020

ConditionsGastric Cancer

InterventionsCamrelizumab+Apatinib+Paclitaxel-albumin+S-1

DrugsCamrelizumab+Apatinib+Paclitaxel-albumin+S-1

Overview

Phase: Phase 2
Intervention: Camrelizumab+Apatinib+Paclitaxel-albumin+S-1
Conditions: Gastric Cancer
Sponsor: Beijing Friendship Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: R0 resection rate
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an interventional clinical trial to assess the efficacy and safety of camrelizumab in combination with apatinib mesylate, paclitaxel-albumin and S-1 for translational treatment of gastric cancer.

Registry

clinicaltrials.gov

Start Date

March 1, 2020

End Date

February 28, 2023

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing Friendship Hospital

Responsible Party

Principal Investigator

Zhongtao Zhang

Professor

Beijing Friendship Hospital

Eligibility Criteria

Inclusion Criteria

•age:18～70; expected survival\>3 months
•pathologically diagnosed gastric cancer or esophageal-gastric-junction cancer, being predominantly adenocarcinoma
•no previous treatment of anti-cancer drugs
•ECOG score 0\~2
•CT/MRI/PET-CT diagnosed as unresectable
•no disfunction of major organs
•lab results satisfy the following criteria:
•WBC≥3.5×109/L
•Neutrophil≥1.5×109/L
•Plt≥100×109/L

Exclusion Criteria

•patients with positive HER-2 test
•with conditions that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction
•allergic to carrizumab for injection, apatinib mesylate, paclitaxel for injection (albumin binding type) and tS-1 or relevant drug excipients; allergic to any other monoclonal antibodies; cannot tolerate radiation toxicity;
•with active autoimmune disease or autoimmune disease history, such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy); patients with complete remission of childhood asthma and require no intervention can be included, whereas those who need medical intervention with bronchodilator cannot be included
•with congenital or acquired immune defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive, and HCV-RNA higher than the lower detection limit of the analysis method) or combined hepatitis B and hepatitis C co infection
•immunosuppressive drugs were used within 14 days before the first use of the study drug, excluding nasal spray and inhaled corticosteroids or systemic steroids in physiological dose (i.e. no more than 10 mg / day of prednisolone or other corticosteroids for equivalent amount);
•inoculated live attenuated vaccine within 4 weeks before the first administration or during the study period
•severe infection (requiring intravenous drip of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first administration, or fever\> 38.5° C of unknown cause during screening / before the first administration
•known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
•objective evidence indicating previous or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced pneumonia, drug-related pneumonia, severe impairment of lung function, etc