Last updated: December 15, 2021
Sponsor: Fujian Medical University Union Hospital
Overall Status: Active - Recruiting
Phase
1/2
Condition
Esophageal Cancer
Vaccines
Esophageal Disorders
Treatment
N/AClinical Study ID
NCT05176002
NIRE UNION
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed written informed consent prior to the implementation of any trial-relatedrocedures;
- Male or female, ≥18 years of age or ≤75 years of age;
- Patients with a confirmed diagnosis of esophageal squamous cell carcinoma bypathological histology of the primary site biopsy;
- Patients who are judged to be operable and in need of neoadjuvant therapy by imagingand esophagoscopy ( cT1b-2N+/ cT3-4aN0-3M0), stage II-IVA;
- The main body of the patient's tumor is located in the mid- and lower thoracic segmentof the esophagus as judged by imaging and esophagoscopy (the central location of thetumor is horizontally below the arch of the odd vein, measured endoscopically ≥ 24 cmfrom the incisors);
- There is at least one imaging measurable lesion according to the solid tumor efficacyevaluation criteria (RECIST version 1.1);
- The patient Have not received any prior antitumor therapy, including but not limitedto surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.;
- ECOG score 0-1;
- Adequate organ function, subjects need to meet the following laboratory indices:
- Absolute neutrophil count (ANC) ≥ 1.5x109/L in the last 14 days withoutgranulocyte colony-stimulating factor ;
- Platelets ≥ 100 x 109/L in the absence of blood transfusion in the last 14 days;
- Hemoglobin >9 g/dL without blood transfusion or erythropoietin in the last 14days;
- Total bilirubin ≤1.5 x upper limit of normal (ULN); or total bilirubin >ULN butdirect bilirubin ≤ ULN;
- Portaline aminotransferase (AST), alanine aminotransferase (ALT) at ≤2.5×ULN;
- blood creatinine ≤ 1.5 x ULN and creatinine clearance (calculated using theCockcroft-Gault formula) ≥ 60 ml/min;
- good coagulation function, defined as international normalized ratio (INR) orprothrombin time (PT) ≤ 1.5 times ULN;
- normal thyroid function, defined as thyroid stimulating hormone (TSH) within thenormal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be enrolled;
- Myocardial enzyme profile within the normal range (simple laboratoryabnormalities that are not clinically significant, as determined by theinvestigator, are also allowed).
- For female subjects of childbearing potential, a negative urine or serum pregnancytest should be performed within 3 days prior to the first dose of study drug (Cycle 1,Day 1). If a negative urine pregnancy test result cannot be confirmed, a bloodpregnancy test will be requested. Non-reproductive females are defined as being atleast 1 year post-menopausal or having undergone surgical sterilization orhysterectomy;
- If there is a risk of conception, all subjects (male or female) are required to usecontraception with an annual failure rate of less than 1% throughout the treatmentperiod up to 120 days after the final study drug dose.
Exclusion
Exclusion Criteria:
- patients with an untreated diagnosis of another malignancy within 5 years prior to thefirst dose (excluding radically treated basal cell carcinoma of the skin, squamousepithelial carcinoma of the skin, and/or radically resected carcinoma in situ)
- patients at risk for tracheoesophageal fistula or aortoesophageal fistula
- currently participating in an interventional clinical study treatment or have receivedanother study drug or been treated with an investigational device within 4 weeks priorto the first dose
- have received prior therapy with: an anti-PD-1, anti-PD-L1 or anti-PD-L2 drug or adrug targeting another stimulatory or co-suppressive T-cell receptor (e.g., CTLA-4,OX-40, CD137).
- systemic systemic therapy with a proprietary Chinese medicine or immunomodulatoryagent (including thymidine, interferon, interleukin, except for local use to controlpleural fluid) with an antitumor indication within 2 weeks prior to the first dose.
- active autoimmune disease requiring systemic therapy (e.g., with disease-relievingdrugs, glucocorticoids, or immunosuppressive agents) that occurred within 2 yearsprior to the first dose. Alternative therapies (e.g., thyroxine, insulin, orphysiologic glucocorticoids for adrenal or pituitary insufficiency) are not consideredsystemic therapy.
- is receiving systemic glucocorticoid therapy (excluding nasal spray, inhaled or otherroutes of topical glucocorticoids) or any other form of immunosuppressive therapywithin 7 days prior to the first dose of the study. Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent)are permitted.
- known allogeneic organ transplantation (except corneal transplantation) or allogeneichematopoietic stem cell transplantation
- known hypersensitivity to the active ingredient or excipients of the investigationaldrug Camrelizumab;
- those with multiple factors affecting oral drug administration (e.g., inability toswallow, post-gastrectomy, chronic diarrhea, and intestinal obstruction)
- have not recovered sufficiently from toxicity and/or complications from anyintervention prior to initiation of therapy (i.e., ≤ grade 1 or at baseline, excludingmalaise or alopecia)
- known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections
- live vaccination within 30 days prior to the first dose (Cycle 1, Day 1). Note:Injectable inactivated viral vaccine for seasonal influenza within 30 days prior tothe first dose is permitted; however, intranasal administration of live attenuatedinfluenza vaccine is not permitted.
- women who are pregnant or breastfeeding.
- Presence of any serious or uncontrollable systemic disease, such as
- Resting ECG with significant and severely symptomatic uncontrollableabnormalities in rhythm, conduction or morphology, such as complete left bundlebranch block, second degree or greater heart block, ventricular arrhythmia oratrial fibrillation.
- Unstable angina, congestive heart failure, chronic heart failure of New YorkHeart Association (NYHA) classification ≥ 2.
- myocardial infarction within 6 months prior to randomization
- suboptimal blood pressure control (systolic blood pressure > 140 mmHg anddiastolic blood pressure > 90 mmHg)
- history of non-infectious pneumonia requiring glucocorticoid therapy within 1year prior to first dose, or current clinically active interstitial lung disease.
- active pulmonary tuberculosis.
- the presence of an active or uncontrolled infection requiring systemic therapy
- presence of clinically active diverticulitis, abdominal abscesses,gastrointestinal obstruction
- the presence of liver disease such as cirrhosis, decompensated liver disease,acute or chronic active hepatitis
- poorly controlled diabetes mellitus (fasting blood glucose (FBG) > 10 mmol/L)
- urine routine suggesting urine protein ≥++ and confirmed 24-hour urine proteinquantification >1.0 g
- patients with mental disorders and unable to cooperate with treatment
- have a medical history or evidence of disease that may interfere with the results ofthe trial, prevent the subject from participating in the study throughout, abnormaltreatment or laboratory test values, or other conditions that the investigatorconsiders unsuitable for enrollment The investigator considers that there are otherpotential risks unsuitable for participation in this study.
Study Design
Total Participants: 26
Study Start date:
September 23, 2021
Estimated Completion Date:
September 30, 2024
Connect with a study center
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaActive - Recruiting
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