About this trial
This project intends to study the efficacy and safety of camrelizumab combined with chemotherapy followed by radiotherapy in the perioperative treatment of AEG.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subjects aged from 18 to 80 years old;
Patients with pathologically confirmed gastroesophageal junction adenocarcinoma (Siewert II-III)
Resectable tumors with staging t3-4N0M0 or T1-4N+M0 confirmed by CT or MRI according to AJCC version 8 staging System;
Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
Disqualifiers
Previous malignant disease within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast);
Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); The subjects with childhood asthma who had been completely relieved and did not need any intervention or vitiligo in adulthood could be included, but the subjects who needed bronchodilator for medical intervention could not be included;
Patients with congenital or acquired immune deficiency, 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 detection limit of the analytical method), or co infection of hepatitis B and hepatitis C;
Active tuberculosis;
Trial design
Single group
Treatments tested in this trial
Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy
DrugDurg:Camrelizumab: 200mg, iv, d1, q3w Durg :Oxaliplatin, 100mg/m2 , iv, d1, q3w Durg :Paclitaxel(Albumin Bound), 125mg/m2, iv, d1, d8, q3w; Durg :Radiotherapy, PGTV:45.1Gy/2.05Gy/ 22f; PTV:40.04Gy/1.82Gy/ 22f;Five days a week for more than four weeks
Treatment groups
Trial outcomes
Primary outcomes
Pathologic complete response (PCR)
pCR rate is defined as the percentage of patients, relative to the total of enrolled subjects,achieving complete histological regression with no available tumor cells yT0N
Secondary outcomes
3 years-Overall Survival (3y-OS)
Percentage of patients who survived 3 years after the start of randomized treatment
years-Event free survival (3y-EFS)
Proportion of patients with event-free survival at 3 years after randomization
Disesease free survival(DFS)
Proportion of patients with disease-free survival at 3 years after randomization
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 28 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.