Pancreatic CancerPhase 2NCT06151262
A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer
A Phase 2 study testing Trilaciclib+mFOLFIRINOX in people with Pancreatic Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
To observe the incidence of chemotherapy-induced myelosuppression and the safety of Trilaciclib combined with mFOLFIRINOX in patients with advanced pancreatic cancer receiving first-line treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Trilaciclib+mFOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2024to 28 Oct 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- ECOG score 0 or 1
- Expected survival≥12 weeks
- Patients with histologically or cytologically confirmed pancreatic cancer
- Have not received any antineoplastic therapy prior to treatment
- Major organ functions within 7 days prior to treatment shall meet the following criteria: a. Neutrophil count ≥1.5×109 /L； b. Hemoglobin ≥10g/dL； c. Platelet count ≥100×109 /L
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- Biochemical examination shall meet the following standards: a、Total bilirubin(TBIL)≤1.5times the upper limit of normal value(ULN); b、ALT and AST≤1.5×ULN ; c、creatinine clearance(CCr)≥60ml/min
- Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures
- Subjects voluntarily joined the study and signed an informed consent form(ICF)
- It is expected that the patient has good compliance and can follow up the efficacy and adverse reactions according to the protocol requirements
Who cannot join
- Had received systemic antineoplastic therapy
- Pregnant and lactating women. Women of childbearing age had to test a negative pregnancy test within 7 days before enrollment
- Substance abuse, clinical or psychological or social factors that may interfere with informed consent or the conduct of the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
du juan, Doctor, 83106666 ext. 025, dujuanglyy@163.com
About this study
Official title: A Single-arm, Exploratory Clinical Study of Trilaciclib Combined With mFOLFIRINOX Regimen in the Treatment of Patients With Advanced Pancreatic Cancer
To observe the incidence of chemotherapy-induced myelosuppression and the safety of Trilaciclib combined with mFOLFIRINOX in patients with advanced pancreatic cancer receiving first-line treatment.
Read the detailed description
This study was a single-arm, exploratory clinical study. Patients with advanced pancreatic cancer were screened and enrolled according to the inclusion and exclusion criteria described in the study protocol. Informed consent was signed after full communication. Patients with advanced pancreatic cancer who received first-line treatment were treated with Trilaciclib +mFOLFIRINOX. The incidence of chemotherapy-induced myelosuppression was used as the primary endpoint to observe whether Trilaciclib could reduce the occurrence or degree of chemotherapy-induced myelosuppression.
- Conditions
- Pancreatic Cancer
- Being tested
- Trilaciclib+mFOLFIRINOX
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trilaciclib+mFOLFIRINOXDrug
Also called G1T28, CDK 4/6 inhibitor
This was a single-arm, exploratory study of the combination of Trilaciclib and mFOLFIRINOX in patients with advanced pancreatic cancer receiving first-line therapy. Observed the incidence of chemotherapy-induced myelosuppression, and imaging was performed every four cycles to assess tumor response.
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib+mFOLFIRINOX | Experimental | The treatment regimen was as follows:
Trilaciclib 240mg/m2 IV infusion, D1, D2，Q2W； Oxaliplatin 68mg/m2 IV infusion, D1; Irinotecan 135mg/m2 IV infusion D1; leucovorin 400mg/m2 IV infusion D1; 5-FU 2.4g/m2 IV infusion for 46h, D1; A total of 12 cycles of treatment were performed every 14 days as a cycle. Receives: Drug: Trilaciclib+mFOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CIM
Incidence of chemotherapy-induced myelosuppression
Measured: During treatment. Treatment cycles of 14 days continued from the first dose until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (up to 24 months）
Secondary outcomes (3)
OS
Overall survival defined as time from the date of first dose of study drug to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases)
Measured: From date of randomization until the date of death(up to 24 months)
PFS
Progression-free survival (PFS per RECIST 1.1) is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.
Measured: From date of first dose of study drug to radiographic disease progression（Up to 24 months）
Safety and Tolerability
Occurrence and severity of AEs by NCI CTCAE v5.0
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start20 Jan 2024
- Primary completion28 May 2025 (estimated)
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- du juan, M.D., Principal investigator, The Affiliated Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151262
- Sponsor's protocol ID
- 2023-419-02
- Status last verified
- Oct 2023
- First submitted
- 21 Nov 2023
- Last updated
- 23 Feb 2024
- Results posted
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Exploratory Clinical Study of Trilaciclib Combined With mFOLFIRINOX Regimen in the Treatment of Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06151262
- Acronym / sponsor ID
- 2023-419-02
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 28 May 2025 (estimated)
- Study completion
- 28 Oct 2026 (estimated)
- First posted
- 30 Nov 2023 (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.
To observe the incidence of chemotherapy-induced myelosuppression and the safety of Trilaciclib combined with mFOLFIRINOX in patients with advanced pancreatic cancer receiving first-line treatment.
Detailed description
This study was a single-arm, exploratory clinical study. Patients with advanced pancreatic cancer were screened and enrolled according to the inclusion and exclusion criteria described in the study protocol. Informed consent was signed after full communication. Patients with advanced pancreatic cancer who received first-line treatment were treated with Trilaciclib +mFOLFIRINOX. The incidence of chemotherapy-induced myelosuppression was used as the primary endpoint to observe whether Trilaciclib could reduce the occurrence or degree of chemotherapy-induced myelosuppression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib+mFOLFIRINOX | Experimental | Drug: Trilaciclib+mFOLFIRINOXThe treatment regimen was as follows: Trilaciclib 240mg/m2 IV infusion, D1, D2，Q2W； Oxaliplatin 68mg/m2 IV infusion, D1; Irinotecan 135mg/m2 IV infusion D1; leucovorin 400mg/m2 IV infusion D1; 5-FU 2.4g/m2 IV infusion for 46h, D1; A total of 12 cycles of treatment were performed every 14 days as a cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-75 years
- ECOG score 0 or 1
- Expected survival≥12 weeks
- Patients with histologically or cytologically confirmed pancreatic cancer
- Have not received any antineoplastic therapy prior to treatment
Key exclusion criteria (3 listed)
- Had received systemic antineoplastic therapy
- Pregnant and lactating women. Women of childbearing age had to test a negative pregnancy test within 7 days before enrollment
- Substance abuse, clinical or psychological or social factors that may interfere with informed consent or the conduct of the study
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+mFOLFIRINOXAlso: G1T28, CDK 4/6 inhibitorThis was a single-arm, exploratory study of the combination of Trilaciclib and mFOLFIRINOX in patients with advanced pancreatic cancer receiving first-line therapy. Observed the incidence of chemotherapy-induced myelosuppression, and imaging was performed every four cycles to assess tumor response. | Drug | Trilaciclib+mFOLFIRINOX |
Primary outcome
Incidence of CIM
Time frame: During treatment. Treatment cycles of 14 days continued from the first dose until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (up to 24 months）
Incidence of chemotherapy-induced myelosuppression
3 secondary outcomes
OS
Time frame: From date of randomization until the date of death(up to 24 months)
PFS
Time frame: From date of first dose of study drug to radiographic disease progression（Up to 24 months）
Safety and Tolerability
Time frame: Up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
du juan, M.D. principal investigator
The Affiliated Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trilaciclib+mFOLFIRINOX in people with Pancreatic Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 10 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: status not confirmed, as of the sponsor's last update on 23 Feb 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.
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 du juan, M.D. (83106666 ext. 025, dujuanglyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CIM (time frame: During treatment. Treatment cycles of 14 days continued from the first dose until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (up to 24 months）). 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 23 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.