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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Prospective, Randomized, Controlled, Single-center Phase II Clinical Trial of Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy for Locally Advanced Esophageal Cancer.

Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer (NCT06569459) is a Phase 2 interventional studying Esophageal Cancer, sponsored by The First Affiliated Hospital with Nanjing Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Esophageal Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients voluntarily participated in this study, signed the willing to sign a consent form form, and had good compliance; - Age ≥ 18 years old, male or female; - Patients with diagnosed by tissue sample (biopsy-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 clinical stage before treatment was: cT1N2-3M0, cT2-4bN0-3M0, M1 limited to non-regional lymph node metastasis, excluding distant organ metastasis); - 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 investigational therapeutic drugs); - 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 count ≥100×109/L;blood count (hemoglobin) at least 100 g/L in women or 110g/L in men;Serum albumin ≥2.8g/dL;Total bilirubin ≤1.5 × ULN and ALT, AST, and/or AKP≤2.5 × ULN , serum creatinine 1.5 x ULN or creatinine clearance or greater or less 60 ml/min (according to Cockcroft - Gault formula); - 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 within the scope of the expected treatment of anticoagulants can filter); ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion 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 clinical stage before treatment was: cT1N2-3M0, cT2-4bN0-3M0, M1 limited to non-regional lymph node metastasis, excluding distant organ metastasis); * 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 investigational therapeutic drugs); * 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 count ≥100×109/L;Hemoglobin ≥100 g/L in women or 110g/L in men;Serum albumin ≥2.8g/dL;Total bilirubin ≤1.5 × ULN and ALT, AST, and/or AKP≤2.5 × ULN , serum creatinine 1.5 x ULN or creatinine clearance or greater or less 60 ml/min (according to Cockcroft - Gault formula); * 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 within the scope of the expected treatment of anticoagulants can filter); * 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. Exclusion Criteria: * History of esophageal cancer surgery; * Previous history of fistula caused by primary tumor invasion; * High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation; * Subjects 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, targeted therapy; received any study drug within 4 weeks before the first dose of the study drug; within 2 weeks before first use of the drugs need to be given corticosteroid (\> 10 mg daily prednisone dose equivalent) or other immune inhibitors for treatment of the subjects system, except for local inflammation of the esophagus and prevent allergy and nausea, vomiting, use of corticosteroids;Have received an antitumor vaccine or a live vaccine within 4 weeks before the first dose of study drug; * Have any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Patients with vitiligo or cured asthma/allergy in the same year era who did not need any intervention after adulthood were excluded. Patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and patients with type I diabetes treated with stable doses of insulin were eligible. * A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation or allogeneic bone marrow transplantation; * Subjects 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 ventricular arrhythmias requiring clinical intervention; * 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 inflammation on baseline chest imaging or signs and symptoms of infection requiring treatment with oral or intravenous antibiotics within 2 weeks before the first dose of study drug were excluded if prophylactic antibiotics were used. * 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 active pulmonary tuberculosis infection more than 1 year before enrollment but without regular treatment; * 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 or cervical carcinoma in situ; * Judging by the researchers, the participants have other factors that could lead to the forced midway termination of studies..

Treatments Being Tested

DRUG

Trilaciclib Injection [Cosela]

Chemoradiotherapy and immunotherapy with Trilaciclib in the treatment of patients with unresectable locally advanced esophageal squamous cell carcinoma

DRUG

Placebo

Chemoradiotherapy and immunotherapy in the treatment of patients with unresectable locally advanced esophageal squamous cell carcinoma

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06569459), the sponsor (The First Affiliated Hospital with Nanjing Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06569459 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06569459?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06569459?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06569459. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06569459. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.