Gastric CancerPhase 4NCT06499610
Clinical Study of Irinotecan Liposome Combination Therapy for Advanced Gastric Cancer
A Phase 4 study testing Irinotecan Hydrochloride Liposome Injection in people with Gastric Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This study is a single-arm, single-center, exploratory clinical study. It is expected that 44 patients with advanced gastric and gastroesophageal junction adenocarcinoma with first-line treatment failure will be included to receive irinotecan liposomes combined with cindilizumab and renvalatinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Irinotecan Hydrochloride Liposome Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to 15 Oct 2027
- Phase
- Phase 4
- 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
Who may be able to join
- The patient was fully aware of the study and volunteered to participate in and signed the informed consent form (ICF);
- Age≥18 years old;
- Expected survival time of 3 months;
- Patients with pathologically confirmed advanced gastric cancer and adenocarcinoma of the gastroesophageal junction;
- Failure or intolerance of previous first-line anti-tumor therapy;
- CPS 1 was detected by PD-L1 expression level;
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- According to RECIST1.1 criteria, the patient has at least one measurable diameter target lesion (long diameter of tumor lesion CT scan 10mm, short diameter of lymph node lesion CT scan 15mm and scanning layer thickness of 5mm);
- Bone marrow function: neutrophils 1.5109 / L, platelets 100109 / L, and hemoglobin 75g / L;
- The ECOG score is 0-2 points;
- Liver and kidney function: upper limit of 1.5 times normal value of serum creatinine; upper limit of normal value of AST and ALT (upper limit of normal value of 5 times for patients with liver invasion); upper limit of normal value of total bilirubin (upper limit of normal value of 3 times for patients with liver invasion);
- Women of childbearing age must have a negative pregnancy test (serum) within 7 days before enrollment, and must be willing to use appropriate methods for contraception during the trial;
- Consent to provide the histological samples;
Who cannot join
- Allergic reaction to any study drug or its ingredients;
- Patients with severe hepatic and renal insufficiency;
- Have used a strong CYP3A4 inducer within 2 weeks before the first dose of the trial drug, or have used a strong CYP3A4 inhibitor or a strong UGT1A1 inhibitor within 1 week;
- Uncontrollable systemic diseases (such as advanced infection, uncontrolled hypertension, diabetes mellitus, etc.);
- Patients with intestinal obstruction and gastrointestinal bleeding;
- According to the HER 2 testing process and evaluation criteria in CSCO Guidelines for Diagnosis and Treatment of Gastric Cancer 2024 edition: confirmed by immunohistochemistry (IHC), HER2 2 + accompanied by in situ hybridization with gene amplification or HER2 3 +;
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- Have any active autoimmune disease or a history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, and reduced thyroid function (which can be included after normal hormone replacement therapy);
- Heart function and disease are one of the following:
- Long QTc syndrome or QTc interval> 480 ms;
- Complete left bundle branch block, degree II or III atrioventricular block;
- Severe, uncontrolled arrhythmias requiring medical therapy;
- New York Society of Cardiology grade III;
- Cardiac ejection fraction (LVEF) below 50%;
- history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically severe pericardial disease, or ECG evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment.
- Uncontrolled ascites and abdominal cavity infection;
- Active infection of hepatitis B and C (positive for HBV surface antigen and 1x103 copies / mL and 1x103 copies / mL);
- Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- Previous or current other malignancies (except basal cell carcinoma of the skin with non-melanoma, carcinoma of the breast / cervix in situ, and other malignancies that have been effectively controlled without treatment in the past five years);
- Pregnant and lactating women and patients of childbearing age who are unwilling to take contraception;
- Other investigator judged ineligible for this study.
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
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Enxiao Li, doctor, 0086-18991232168, doclienxiao@163.com
About this study
Official title: Prospective, Open-label, Single-arm Clinical Study of Irinotecan Liposomes Combined With Cindilizumab and Lunvalatinib as Second-line Treatment for Adenocarcinoma of Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
This study is a single-arm, single-center, exploratory clinical study. It is expected that 44 patients with advanced gastric and gastroesophageal junction adenocarcinoma with first-line treatment failure will be included to receive irinotecan liposomes combined with cindilizumab and renvalatinib. The study unit is the First Affiliated Hospital of Xi'an Jiaotong University. The study included screening period (28 days), treatment period (6 cycles), and follow-up period. Subjects signed the informed consent and underwent baseline examination during the screening period, patients meeting the exclusion criteria entered the treatment period, and all subjects completed the protocol to observe safety, tolerability and efficacy. The same subject received only one dosing schedule during the study period. The follow-up period begins after the end of the treatment period.
Read the detailed description
This study is an exploratory clinical study. It is expected to include 44 patients with second-line advanced gastric and gastroesophageal junction adenocarcinoma, all treated with irinotecan liposome combined with cindilizumab and lunvatinib.
The dosing regimen of irinotecan liplex injection was 70 mg / m2, cindilizmab 200mg, and valatinib 8-12mg (dose determined by body weight), every 3 weeks, every 2 treatment cycles (every 6 weeks). The subject is scheduled to receive 6 cycles of treatment, or develop intolerable toxicity, or terminate the study for other reasons.
The study included screening period (within 28 days), treatment period (6 cycles) and follow-up period. Subjects signed the informed consent and underwent baseline examination during the screening period, patients meeting the exclusion criteria entered the treatment period, and all subjects completed the protocol to observe safety, tolerability and efficacy. The same subject received only one dosing schedule during the study period. The follow-up period begins after the end of the treatment period.
- Conditions
- Gastric Cancer
- Being tested
- Irinotecan Hydrochloride Liposome Injection
- Keywords
- Irinotecan lipoposomes, And adenocarcinoma of advanced gastric cancer and gastroesophageal junction, Second line treatment
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan Hydrochloride Liposome InjectionDrug
Also called Sintilimab Injection, Lenvatinib Mesilate Capsules
At the dose of 70mg / m2, for patients homozygous for UGT1A1 * 28, the first dose of irinotecan was adjusted to 50mg / m2,70mg / m2 if the patient tolerated during the first cycle and 70 mg / m 2 in the subsequent cycle; add 500 mL of 5% glucose injection or 0.9% sodium chloride injection for intravenous infusion within 90 minutes. On the first day of each treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | therapeutic measure： Irinotecan hydrochloride for liposome injection 70mg/m2，intravenous drip，d1 Sintilimab Injection 200mg，intravenous drip，d1 Lenvatinib Mesilate Capsules ，8mg (weight<60kg) or 12mg (weight≥60kg) ,po, qd Receives: Drug: Irinotecan Hydrochloride Liposome Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial progression-free survival
Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
Measured: Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
Secondary outcomes (4)
Intracranial Objective response rate
The number (%) of patients defined as complete or partial response, assessed using the investigator, version 1.1 (RECIST 1.1), was from the enrollment of subjects to the end of chemotherapy.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Intracranial Disease Control Rate
The percentage of subjects who have a best response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator, was from the enrollment of subjects to the end of chemotherapy.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Overall Survival
Overall survival is defined as the time from beginning of treatment until death due to any cause and will be assessed up to 3 years.
Measured: The time from beginning of treatment until death due to any cause and will be assessed up to 3 years.
Safety/Adverse event
Incidence of Adverse Events (AEs): Incidence, severity and seriousness of adverse events, incidence of serious adverse events (SAEs), which usually be graded by CTCAE v5.0 based on current clinical practice.
Measured: From the recorded first treatment to 4 weeks after the recorded last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li EnXiao, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Enxiao Li, doctor, Principal investigator, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499610
- Sponsor's protocol ID
- 2024-102
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label, Single-arm Clinical Study of Irinotecan Liposomes Combined With Cindilizumab and Lunvalatinib as Second-line Treatment for Adenocarcinoma of Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06499610
- Acronym / sponsor ID
- 2024-102
- Conditions
- Gastric Cancer
- Keywords
- Irinotecan lipoposomes, And adenocarcinoma of advanced gastric cancer and gastroesophageal junction, Second line treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 12 Jul 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.
This study is a single-arm, single-center, exploratory clinical study. It is expected that 44 patients with advanced gastric and gastroesophageal junction adenocarcinoma with first-line treatment failure will be included to receive irinotecan liposomes combined with cindilizumab and renvalatinib. The study unit is the First Affiliated Hospital of Xi'an Jiaotong University. The study included screening period (28 days), treatment period (6 cycles), and follow-up period. Subjects signed the informed consent and underwent baseline examination during the screening period, patients meeting the exclusion criteria entered the treatment period, and all subjects completed the protocol to observe safety, tolerability and efficacy. The same subject received only one dosing schedule during the study period. The follow-up period begins after the end of the treatment period.
Detailed description
This study is an exploratory clinical study. It is expected to include 44 patients with second-line advanced gastric and gastroesophageal junction adenocarcinoma, all treated with irinotecan liposome combined with cindilizumab and lunvatinib.
The dosing regimen of irinotecan liplex injection was 70 mg / m2, cindilizmab 200mg, and valatinib 8-12mg (dose determined by body weight), every 3 weeks, every 2 treatment cycles (every 6 weeks). The subject is scheduled to receive 6 cycles of treatment, or develop intolerable toxicity, or terminate the study for other reasons.
The study included screening period (within 28 days), treatment period (6 cycles) and follow-up period. Subjects signed the informed consent and underwent baseline examination during the screening period, patients meeting the exclusion criteria entered the treatment period, and all subjects completed the protocol to observe safety, tolerability and efficacy. The same subject received only one dosing schedule during the study period. The follow-up period begins after the end of the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Irinotecan Hydrochloride Liposome Injectiontherapeutic measure： Irinotecan hydrochloride for liposome injection 70mg/m2，intravenous drip，d1 Sintilimab Injection 200mg，intravenous drip，d1 Lenvatinib Mesilate Capsules ，8mg (weight<60kg) or 12mg (weight≥60kg) ,po, qd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The patient was fully aware of the study and volunteered to participate in and signed the informed consent form (ICF);
- Age≥18 years old;
- Expected survival time of 3 months;
- Patients with pathologically confirmed advanced gastric cancer and adenocarcinoma of the gastroesophageal junction;
- Failure or intolerance of previous first-line anti-tumor therapy;
Key exclusion criteria (20 listed)
- Allergic reaction to any study drug or its ingredients;
- Patients with severe hepatic and renal insufficiency;
- Have used a strong CYP3A4 inducer within 2 weeks before the first dose of the trial drug, or have used a strong CYP3A4 inhibitor or a strong UGT1A1 inhibitor within 1 week;
- Uncontrollable systemic diseases (such as advanced infection, uncontrolled hypertension, diabetes mellitus, etc.);
- Patients with intestinal obstruction and gastrointestinal bleeding;
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 |
|---|---|---|
| Irinotecan Hydrochloride Liposome InjectionAlso: Sintilimab Injection, Lenvatinib Mesilate CapsulesAt the dose of 70mg / m2, for patients homozygous for UGT1A1 * 28, the first dose of irinotecan was adjusted to 50mg / m2,70mg / m2 if the patient tolerated during the first cycle and 70 mg / m 2 in the subsequent cycle; add 500 mL of 5% glucose injection or 0.9% sodium chloride injection for intravenous infusion within 90 minutes. On the first day of each treatment cycle. | Drug | experimental group |
Primary outcome
Intracranial progression-free survival
Time frame: Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
4 secondary outcomes
Intracranial Objective response rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Intracranial Disease Control Rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Overall Survival
Time frame: The time from beginning of treatment until death due to any cause and will be assessed up to 3 years.
Safety/Adverse event
Time frame: From the recorded first treatment to 4 weeks after the recorded last treatment
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 12 Jul 2024.
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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.
Enxiao Li, doctor principal investigator
First Affiliated Hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Irinotecan Hydrochloride Liposome Injection in people with Gastric Cancer, run by First Affiliated Hospital Xi'an Jiaotong 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 12 inclusion and 20 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: opening soon, as of the sponsor's last update on 12 Jul 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Enxiao Li, doctor (18991232168, doclienxiao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial progression-free survival (time frame: Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 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 12 Jul 2024.