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New treatment option for Esophageal Cancer
Official title Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer
ClinicalTrials.gov ID: NCT06569459
What this study is testing
What is Trilaciclib Injection [Cosela]?
Trilaciclib Injection [Cosela] is an investigational medicine, being studied as a potential treatment for esophageal cancer.
Also referred to as G1T28, CDK 4/6 inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a double-arm, randomized, controlled, single-center, phase II clinical trial aimed at evaluating the efficacy and safety of chemoradiotherapy plus immunotherapy with or without Trilaciclib in the treatment of locally advanced esophageal squamous cell carcinoma that is not resectable.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients voluntarily participated in this study, signed the informed consent form, and had good compliance;
- Age ≥ 18 years old, male or female;
- Patients with histologically confirmed locally advanced esophageal squamous cell carcinoma at stage II-IV that is unresectable, or where surgery is...
- The presence of at least one measurable lesion according to the response evaluation criteria in solid Tumors (RECIST1.1);
- Have not received any systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted drug therapy...
You likely can't join if
- History of esophageal cancer surgery;
- Previous history of fistula caused by primary tumor invasion;
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation;
- people with poor nutritional status, who lost more than 10% of their body weight within 2 months before screening, had no significant improvement...
- major surgery or severe trauma within 4 weeks before the first dose of study drug;
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 7. Have received or are receiving any of the...
See the full eligibility criteria
- Patients voluntarily participated in this study, signed the informed consent form, and had good compliance;
- Age ≥ 18 years old, male or female;
- Patients with histologically confirmed locally advanced esophageal squamous cell carcinoma at stage II-IV that is unresectable, or where surgery is contraindicated or refused (according to the AJCC 8th edition, the...
- The presence of at least one measurable lesion according to the response evaluation criteria in solid Tumors (RECIST1.1);
- Have not received any systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted drug therapy, immunotherapy, biological therapy, local therapy, and other...
- ECOG: 0-1 ;
- Expected survival time ≥ 6 months;
- Vital organ function meets the following requirements (no blood components and cell growth factors are allowed for 2 weeks before the start of screening examination) ：Absolute neutrophil count (ANC) ≥1.5×109/L；Platelet...
- International standardization ratio (INR) and part activated clotting time (APTT) live enzymes acuities were 1.5 x ULN (for the use of stable doses of anticoagulants such as: low molecular heparin or warfarin and INR...
- Women: All women of childbearing potential must have a negative serum pregnancy test at screening and must be using reliable contraception from written informed consent until 3 months after last dose.
- History of esophageal cancer surgery;
- Previous history of fistula caused by primary tumor invasion;
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation;
- people with poor nutritional status, who lost more than 10% of their body weight within 2 months before screening, had no significant improvement after nutritional intervention;
- major surgery or severe trauma within 4 weeks before the first dose of study drug;
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 7. Have received or are receiving any of the following：Anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy...
- Have any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism)...
- A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation or allogeneic bone marrow transplantation;
- people with uncontrolled cardiac clinical symptoms or diseases such as： (1) heart failure NYHA II or higher； (2) unstable angina ；(3) myocardial infarction within 1 year ；(4) clinically significant supraventricular or...
- Severe infection (CTC AE \> 2) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; Patients with active pulmonary...
- History of interstitial lung disease, non-infectious pneumonia, pulmonary function test confirmed ≥ grade 3 pulmonary dysfunction;
- Patients with active pulmonary tuberculosis infection detected by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of...
- The subject has active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the analytical method);
- There were more than grade 1 abnormal sodium, potassium, and calcium laboratory test values within 2 weeks before enrollment, which could not be improved after treatment;
- Allergy to any study drug or its components;
- Prior hematopoietic stem cell or bone marrow transplantation;
- Any other malignancy diagnosed before the first use of study drug, except those with a low risk of metastasis and death (5-year survival rate \> 90%), such as adequately treated basal cell or squamous cell skin cancer...
- Judging by the researchers, the participants have other factors that could lead to the forced midway termination of studies..
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.