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Esophageal CancerPhase 2NCT06569459

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

A Phase 2 study testing Trilaciclib Injection [Cosela] in people with Esophageal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
Trilaciclib Injection [Cosela]
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
9 Jul 2024to 31 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 ;
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  • 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.

Who cannot join

  • 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;
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  • 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..

Trial locations and contacts

1 site in 1 country.

Xiaolin Ge, PHD contact

83714511 ext. 025

doctorsxl@163.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Xiao L Ge, PHD, 83714511 ext. 025, doctorsxl@163.com

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

The subjects included in the study will receive Trilaciclib combined with chemoradiotherapy and immunosuppressant group ( the experimental group) and chemoradiotherapy combined with immunosuppressant group ( the control group). The experimental group and the control group were treated with 4 cycles of treatment. If the efficacy was evaluated as non-progressive after 4 cycles of treatment, the experimental group and the control group continued immunosuppressive therapy until disease progression or intolerance. The incidence of grade ≥3 neutropenia during chemotherapy was used as the primary endpoint.

Being tested
Trilaciclib Injection [Cosela], Placebo
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trilaciclib Injection [Cosela]Drug

    Also called G1T28, CDK 4/6 inhibitor

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

  • PlaceboDrug

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

Study groups in NCT06569459
Study groupRoleWhat they receive
Experimental groupExperimentalTrilaciclib 240mg/m2；Radiation therapy：50.4Gy/28/1.8；Paclitaxel: 135mg/m2, d1, Q3W, 4 cycles；Carboplatin: AUC=5, d2, Q3W, 4 cycles（or nedaplatin 75 mg/m2, d2, Q3W, 4 cycles）;Immune inhibitors (by choice) : d1, Q3W, treatment + maintain phase, continuous dosing, until disease progression or not tolerated toxicity.
Receives: Drug: Trilaciclib Injection [Cosela]
Control groupSham comparatorRadiation therapy：50.4Gy/28/1.8；Paclitaxel: 135mg/m2, d1, Q3W, 4 cycles；Carboplatin: AUC=5, d2, Q3W, 4 cycles（or nedaplatin 75 mg/m2, d2, Q3W, 4 cycles）;Immune inhibitors (by choice) : d1, Q3W, treatment + maintain phase, continuous dosing, until disease progression or not tolerated toxicity.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of grade ≥3 neutropenia

    Incidence of grade ≥3 neutropenia

    Measured: during Trilaciclib plus chemotherapy assessed up to 84 days

Secondary outcomes (4)

  1. Incidence of G-CSF treatment

    Incidence of G-CSF treatment

    Measured: during Trilaciclib plus chemotherapy assessed up to 1 years

  2. Incidence of platelet transfusion

    Incidence of platelet transfusion

    Measured: during Trilaciclib plus chemotherapy assessed up to 1 years

  3. Incidence of grade ≥3 anemia

    Incidence of grade ≥3 anemia

    Measured: during Trilaciclib plus chemotherapy assessed up to 84 days

  4. Incidence of grade ≥3 thrombocytopenia

    Incidence of grade ≥3 thrombocytopenia

    Measured: during Trilaciclib plus chemotherapy assessed up to 84 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start9 Jul 2024
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06569459
Sponsor's protocol ID
COSELA-ESCC-01
Status last verified
Aug 2024
First submitted
23 Jul 2024
Last updated
26 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trilaciclib Injection [Cosela] in people with Esophageal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaolin Ge, PHD (83714511 ext. 025, doctorsxl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of grade ≥3 neutropenia (time frame: during Trilaciclib plus chemotherapy assessed up to 84 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06569459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.

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