A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer: a Single-center, Open-label, Randomized Controlled Trial

Shanghai Minimally Invasive Surgery Center1 site in 1 country100 target enrollmentJuly 1, 2022

ConditionsGastric Cancer

Interventionscamrelizumab+chemotherapy Chemotherapy

Drugscamrelizumab+chemotherapy Chemotherapy

Overview

Phase: Phase 1
Intervention: camrelizumab+chemotherapy
Conditions: Gastric Cancer
Sponsor: Shanghai Minimally Invasive Surgery Center
Enrollment: 100
Locations: 1
Primary Endpoint: major pathologic response rate
Status: Suspended
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

It is a single-center, open-lable, randomized controlled trial to prospectively investigate the effectiveness and safety of Camrelizumab combined with DOS regimen chemotherapy in neoadjuvant treatment of patients with locally advanced gastric cancer.

Registry

clinicaltrials.gov

Start Date

July 1, 2022

End Date

January 1, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Minimally Invasive Surgery Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
•Male or female patients between the ages of 18-75;
•Patients diagnosed as gastric adenocarcinoma by histology or cytology;
•Stage: Locally advanced stage (T3-4aN1-3M0);
•Have not received other immunotherapy drugs or chemotherapy drugs in the past;
•ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points;
•Has sufficient organ and bone marrow function

Exclusion Criteria

•Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)\];
•A distant metastasis occurs;
•Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
•Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
•Patients with any severe and/or uncontrollable disease；
•Patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction
•Patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
•Received glucocorticosteroid or immunosuppressive therapy within 7 days before grouping;
•Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture
•Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;

Arms & Interventions

camrelizumab+chemotherapy

neoadjuvant treatment with camrelizumab+chemotherapy

Intervention: camrelizumab+chemotherapy

chemotherapy

neoadjuvant treatment with chemotherapy

Intervention: Chemotherapy

Outcomes

Primary Outcomes

major pathologic response rate

Time Frame: one month after surgery

complete or subtotal regression (\<10% residual tumor per tumor bed)

Secondary Outcomes

complete pathologic response rate(one month after surgery)
Overall survival(3 years)
perioperative complications(the time from the start of randomization to 3 months after surgery)
Disease-free survival(3 years)
R0 resection rate(one month after surgery)