ESCCCOSELANCT06698692
Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma
An observational study of ESCC, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Clinical data of patients with synchronous radiotherapy for esophageal cancer in the Department of Radiology of Jiangsu Provincial People's Hospital were collected. Patients were divided into trilaciclib group (34 cases) and control group (169 cases) based on whether trilaciclib was used or not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESCC
- What is being tested?
- Trilaciclib Injection [Cosela]
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2024to 2 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with esophageal squamous carcinoma who received concurrent chemoradiotherapy with or without trilaciclib.
Who may be able to join
- age ≥18 years;
- pathological diagnosis of esophageal squamous cell carcinoma;
- failure to undergo surgical treatment;
- completion of definitive chemoradiotherapy or chemoradiotherapy combined with immunotherapy.
Who cannot join
- history of other malignant tumors;
- difficulty in follow-up;
- insufficient clinical information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Xiaolin Ge, PHD, 87373012, liuxy0229@163.com
Xiaojie Xia, 86+87373012 ext. 025
About this study
Official title: Real-world Assessment of Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma
Clinical data of patients with synchronous radiotherapy for esophageal cancer in the Department of Radiology of Jiangsu Provincial People's Hospital were collected. Patients were divided into trilaciclib group (34 cases) and control group (169 cases) based on whether trilaciclib was used or not. Patients in the trilaciclib group were given trilaciclib before each chemotherapy treatment. Propensity score matching (PSM) was used to balance the baseline characteristics between the two groups on a 1:1 ratio. After pairing, the rates of bone marrow suppression and other adverse events were compared between the two groups.
Read the detailed description
chemoradiotherapy-induced myelosuppression (CIM) is the most common adverse event of concurrent chemoradiotherapy for esophageal cancer, often leading to reduction, delay or even cessation of chemotherapeutic agents. Clinical treatments for CIM mainly include various hematopoietic growth factors and blood transfusion. However, these interventions target only a single spectrum of blood cells and are susceptible to concomitant adverse events such as bone pain, thrombosis, and fever. Trilaciclib is a potent, transient, reversible CDK4/6 inhibitor and is the world's first innovative drug with lineage-wide myeloprotective effects. Its use in esophageal cancer has not been reported yet. In this study, we investigated the clinical efficacy and safety of trilaciclib in preventing myelosuppression in concurrent chemoradiotherapy for esophageal cancer for the first time.
- Conditions
- ESCC
- Being tested
- Trilaciclib Injection [Cosela]
- Keywords
- trilaciclib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trilaciclib Injection [Cosela]Drug
Trilaciclib Combined chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Trilaciclib combined with chemoradiotherapy Receives: Drug: Trilaciclib Injection [Cosela] | |
| Control group | chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade ≥3 neutropenia
Incidence of grade ≥3 neutropenia
Measured: during Trilaciclib plus chemotherapy assessed up to 1 years
Secondary outcomes (1)
Incidence of Adverse Events
The incidence of Adverse Events according to Common Terminology Criteria for Adverse Events
Measured: during Trilaciclib plus chemotherapy assessed up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start2 Apr 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion2 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESCCStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiao L Ge, PHD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698692
- Sponsor's protocol ID
- COSELA-ESCC-02
- Acronym
- COSELA
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Assessment of Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06698692
- Acronym / sponsor ID
- COSELA / COSELA-ESCC-02
- Conditions
- ESCC
- Keywords
- trilaciclib
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 2 Apr 2025 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical data of patients with synchronous radiotherapy for esophageal cancer in the Department of Radiology of Jiangsu Provincial People's Hospital were collected. Patients were divided into trilaciclib group (34 cases) and control group (169 cases) based on whether trilaciclib was used or not. Patients in the trilaciclib group were given trilaciclib before each chemotherapy treatment. Propensity score matching (PSM) was used to balance the baseline characteristics between the two groups on a 1:1 ratio. After pairing, the rates of bone marrow suppression and other adverse events were compared between the two groups.
Detailed description
chemoradiotherapy-induced myelosuppression (CIM) is the most common adverse event of concurrent chemoradiotherapy for esophageal cancer, often leading to reduction, delay or even cessation of chemotherapeutic agents. Clinical treatments for CIM mainly include various hematopoietic growth factors and blood transfusion. However, these interventions target only a single spectrum of blood cells and are susceptible to concomitant adverse events such as bone pain, thrombosis, and fever. Trilaciclib is a potent, transient, reversible CDK4/6 inhibitor and is the world's first innovative drug with lineage-wide myeloprotective effects. Its use in esophageal cancer has not been reported yet. In this study, we investigated the clinical efficacy and safety of trilaciclib in preventing myelosuppression in concurrent chemoradiotherapy for esophageal cancer for the first time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Drug: Trilaciclib Injection [Cosela]Trilaciclib combined with chemoradiotherapy |
| Control group | – | –chemoradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with esophageal squamous carcinoma who received concurrent chemoradiotherapy with or without trilaciclib.
Key inclusion criteria (4 listed)
- age ≥18 years;
- pathological diagnosis of esophageal squamous cell carcinoma;
- failure to undergo surgical treatment;
- completion of definitive chemoradiotherapy or chemoradiotherapy combined with immunotherapy.
Key exclusion criteria (3 listed)
- history of other malignant tumors;
- difficulty in follow-up;
- insufficient clinical information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trilaciclib Injection [Cosela]Trilaciclib Combined chemoradiotherapy | Drug | Observation group |
Primary outcome
Incidence of grade ≥3 neutropenia
Time frame: during Trilaciclib plus chemotherapy assessed up to 1 years
Incidence of grade ≥3 neutropenia
1 secondary outcome
Incidence of Adverse Events
Time frame: during Trilaciclib plus chemotherapy assessed up to 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for ESCC
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
Active, not recruiting
Clinical Application of an AI-based Dissection Trajectory Prediction System (ADTPS) in Endoscopic Submucosal Dissection
Esophageal Squamous Cell Carcinoma (ESCC), High-Grade Intraepithelial Neoplasia
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
NSCLC, NSCLC (Advanced Non-small Cell Lung Cancer)
RecruitingPhase 2
QL1706 Plus Celecoxib in Advanced Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiao L Ge, PHD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ESCC, 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 21 Nov 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaolin Ge, PHD (86+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 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.