Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer

Phase 2

Recruiting

• Conditions: Esophageal Cancer

• Registration Number: NCT06569459
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients voluntarily participated in this study, signed the informed consent form,<br> and had good compliance;<br><br> - Age = 18 years old, male or female;<br><br> - Patients with histologically confirmed locally advanced esophageal squamous cell<br> carcinoma at stage II-IV that is unresectable, or where surgery is contraindicated<br> or refused (according to the AJCC 8th edition, the clinical stage before treatment<br> was: cT1N2-3M0, cT2-4bN0-3M0, M1 limited to non-regional lymph node metastasis,<br> excluding distant organ metastasis);<br><br> - The presence of at least one measurable lesion according to the response evaluation<br> criteria in solid Tumors (RECIST1.1);<br><br> - Have not received any systemic anti-tumor therapy (including but not limited to<br> systemic chemotherapy, radiotherapy, molecular targeted drug therapy, immunotherapy,<br> biological therapy, local therapy, and other investigational therapeutic drugs);<br><br> - ECOG: 0-1 ;<br><br> - Expected survival time = 6 months;<br><br> - Vital organ function meets the following requirements (no blood components and cell<br> growth factors are allowed for 2 weeks before the start of screening examination)<br> :Absolute neutrophil count (ANC) =1.5×109/L;Platelet count =100×109/L;Hemoglobin<br> =100 g/L in women or 110g/L in men;Serum albumin =2.8g/dL;Total bilirubin =1.5 × ULN<br> and ALT, AST, and/or AKP=2.5 × ULN<br><br> , serum creatinine 1.5 x ULN or creatinine clearance or greater or less 60 ml/min<br> (according to Cockcroft - Gault formula);<br><br> - International standardization ratio (INR) and part activated clotting time (APTT)<br> live enzymes acuities were 1.5 x ULN (for the use of stable doses of anticoagulants<br> such as: low molecular heparin or warfarin and INR within the scope of the expected<br> treatment of anticoagulants can filter);<br><br> - Women: All women of childbearing potential must have a negative serum pregnancy test<br> at screening and must be using reliable contraception from written informed consent<br> until 3 months after last dose.<br><br>Exclusion Criteria:<br><br> - History of esophageal cancer surgery;<br><br> - Previous history of fistula caused by primary tumor invasion;<br><br> - High risk of gastrointestinal bleeding, esophageal fistula, or esophageal<br> perforation;<br><br> - Subjects with poor nutritional status, who lost more than 10% of their body weight<br> within 2 months before screening, had no significant improvement after nutritional<br> intervention;<br><br> - major surgery or severe trauma within 4 weeks before the first dose of study drug;<br><br> - Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated<br> drainage; 7. Have received or are receiving any of the following:Anti-PD-1 or<br> anti-PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted therapy; received<br> any study drug within 4 weeks before the first dose of the study drug; within 2<br> weeks before first use of the drugs need to be given corticosteroid (> 10 mg daily<br> prednisone dose equivalent) or other immune inhibitors for treatment of the subjects<br> system, except for local inflammation of the esophagus and prevent allergy and<br> nausea, vomiting, use of corticosteroids;Have received an antitumor vaccine or a<br> live vaccine within 4 weeks before the first dose of study drug;<br><br> - Have any active autoimmune disease or history of autoimmune disease (e.g.,<br> interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis,<br> myocarditis, nephritis, hyperthyroidism, hypothyroidism); Patients with vitiligo or<br> cured asthma/allergy in the same year era who did not need any intervention after<br> adulthood were excluded. Patients with autoimmune-mediated hypothyroidism treated<br> with stable doses of thyroid replacement hormone and patients with type I diabetes<br> treated with stable doses of insulin were eligible.<br><br> - A history of immunodeficiency, including HIV positive, other acquired or congenital<br> immunodeficiency diseases, or organ transplantation or allogeneic bone marrow<br> transplantation;<br><br> - Subjects with uncontrolled cardiac clinical symptoms or diseases such as: (1) heart<br> failure NYHA II or higher; (2) unstable angina ;(3) myocardial infarction within 1<br> year ;(4) clinically significant supraventricular or ventricular arrhythmias<br> requiring clinical intervention;<br><br> - Severe infection (CTC AE > 2) occurred within 4 weeks before the first dose of study<br> drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious<br> complications; Patients with active pulmonary inflammation on baseline chest imaging<br> or signs and symptoms of infection requiring treatment with oral or intravenous<br> antibiotics within 2 weeks before the first dose of study drug were excluded if<br> prophylactic antibiotics were used.<br><br> - History of interstitial lung disease, non-infectious pneumonia, pulmonary function<br> test confirmed = grade 3 pulmonary dysfunction;<br><br> - Patients with active pulmonary tuberculosis infection detected by medical history or<br> CT examination, or with a history of active pulmonary tuberculosis infection within<br> 1 year before enrollment, or with a history of active pulmonary tuberculosis<br> infection more than 1 year before enrollment but without regular treatment;<br><br> - The subject has active hepatitis B (HBV DNA = 2000 IU/mL or 104 copies/mL),<br> hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of<br> the analytical method);<br><br> - There were more than grade 1 abnormal sodium, potassium, and calcium laboratory test<br> values within 2 weeks before enrollment, which could not be improved after<br> treatment;<br><br> - Allergy to any study drug or its components;<br><br> - Prior hematopoietic stem cell or bone marrow transplantation;<br><br> - Any other malignancy diagnosed before the first use of study drug, except those with<br> a low risk of metastasis and death (5-year survival rate > 90%), such as adequately<br> treated basal cell or squamous cell skin cancer or cervical carcinoma in situ;<br><br> - Judging by the researchers, the participants have other factors that could lead to<br> the forced midway termination of studies..

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of grade =3 neutropenia

Secondary Outcome Measures

Name	Time	Method
Incidence of G-CSF treatment;Incidence of platelet transfusion;Incidence of grade =3 anemia;Incidence of grade =3 thrombocytopenia