Gastric CancerPhase 2NCT06697366

Liposomal Irinotecan Combined with Sintilimab for Second-line Treatment of Progressive Gastric Cancer

A Phase 2 study testing Irinotecan liposome injection Ⅱ and Sintilimab in people with Gastric Cancer, run by Ruijin Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Evaluating the efficacy and safety of irinotecan liposome injection in combination with Sintilimab in the second-line treatment of progressive gastric cancer Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastric Cancer
What is being tested?: Irinotecan liposome injection Ⅱ and Sintilimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: No sites listed yet
Study dates: 20 Nov 2024to 20 Nov 2026
Phase: Phase 2
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-75 years old, gender is not limited;
Pathologically confirmed adenocarcinoma (originating from the stomach and gastroesophageal junction);
Clinical documentation of failure of prior standard therapy (treatment with at least 1 cycle of standard chemotherapy regimen, disease progression or intolerance during treatment, or disease progression after completion of treatment).
An Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 2;
Have equivalent organ function, i.e., meet the following criteria:
a.Routine blood tests:

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Neutrophils ≥ 1.5 × 109 /L;
Leukocytes ≥ 3.5 × 109 /L;
Platelets ≥ 75 × 109 /L;
hemoglobin ≥70 g/L; b. Biochemical examination:
Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (subjects with biliary obstruction, after biliary drainage ≤ 5 × ULN);
≤ 5 x ULN for alanine aminotransferase (AST) and alanine aminotransferase (ALT) in subjects with liver metastases
Albumin level ≥ 28 g/L;
creatinine clearance ≥ 60 ml/min; c.Cardiac function tests:
normal ECG or abnormal ECG (not clinically significant in the judgment of the investigator)
Left ventricular ejection fraction (LVEF) ≥ low limit of normal;
Previous surgery, radiotherapy, chemotherapy or other anti-tumor treatment need to end the treatment for 4 weeks or more, and the general physical condition or related adverse reactions have recovered (toxic reaction ≤ grade 1) or reached a stable state;
Participate voluntarily and sign the informed consent form;
Good compliance, agree to cooperate with the survival follow-up.

Who cannot join

Patients previously treated with irinotecan;
Subjects with ascites requiring clinical intervention (including subjects with moderate to large amounts of ascites, if the subject's ascites needs to be stabilized for more than 4 weeks after drainage);
Clinically significant gastrointestinal-like illness (including bleeding, infectious inflammation, perforation, obstruction, or diarrhea greater than grade 1);
second primary malignant tumor within 5 years (except for cured carcinoma in situ, basal or squamous cell skin cancer; subjects with other previous neoplasms that have not recurred within 5 years may be enrolled);
Suffering from uncontrolled cardiac or cerebral diseases or clinical symptoms, including but not limited to: ① NYHA class III or higher heart failure; ② unstable angina; ③ myocardial infarction or stroke within 6 months; ④ supraventricular or ventricular arrhythmia requiring treatment or intervention; ⑤ uncontrollable hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg after optimal treatment) ;
Subjects with known active hepatitis B (HBsAg positive and HBV DNA ≥ 103 copies or ≥ 1000 U/ml);

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Active infection or unexplained fever >38.5°C during the Screening Period or on the day of dosing (in the investigator's judgment, fever due to neoplasia may be enrolled), which, in the investigator's judgment, would interfere with the subject's participation in this trial or interfere with the evaluation of efficacy;
Known hypersensitivity to any component of irinotecan hydrochloride liposomes or other liposomes;
Pregnant or lactating women;
Positive screening blood (urine) pregnancy test in women of childbearing potential (male and female subjects should use reliable contraception to prevent pregnancy during the trial and for 3 months after the last dose);
other medical or social problems that, in the judgment of the investigator, may affect the subject's ability to sign an informed consent, to participate in the trial study, or to influence the interpretation of the trial results.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hao Li, MD, PhD contact

15000660260

lh11001@rjh.com.cn

About this study

Official title: Liposomal Irinotecan in Combination with Sintilimab in Second-Line Treatment of Progressive Gastric Cancer, a Single-Arm, Single-Center, Open-Label, Phase II Clinical Study

Evaluating the efficacy and safety of irinotecan liposome injection in combination with Sintilimab in the second-line treatment of progressive gastric cancer

Read the detailed description

This is a single-center, open, single-arm clinical study to evaluate the efficacy and safety of irinotecan liposome injection in combination with Sintilimab in the second-line treatment of progressed gastric cancer, and to provide more clinical treatment options for gastric cancer patients.

Conditions: Gastric Cancer
Being tested: Irinotecan liposome injection Ⅱ, Sintilimab
Keywords: gastric cancer, irinotecan liposome, Sintilimab, 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 liposome injection ⅡDrug
56.6 mg/m2，Q3W
SintilimabDrug
200mg，Q3W

Study groups in NCT06697366
Study group	Role	What they receive
treatment	Experimental	The patients with Progressive Stage Gastric Cancer will be enrolled and given Sintilimab: 200 mg over 1 hour IV, given every 3 weeks. Irinotecan Liposome Injection II: 56.6 mg/m2 (free base) every 3 weeks, depending on the dose. Sequence of administration: Sindilizumab and Irinotecan Liposome Injection II will be given sequentially. Pre-treatment medication: Dexamethasone and antiemetic (or prophylactic irinotecan if preferred according to hospital practice). Receives: Drug: Irinotecan liposome injection Ⅱ; Drug: Sintilimab

What is being measured

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

overall response rate,ORR
the best response rate
Measured: up to two years

Secondary outcomes (3)

progression free survival,PFS
from first dose treatment to disease progression
Measured: up to two years
Disease control rate,DCR
Proportion of cases with complete remission, partial remission and stabilization of lesions
Measured: up to two years
adverse events, AE
treatment related adverse events, TRAEs
Measured: up to two years

Timeline

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

20 Nov 202420 Nov 2026

First posted20 Nov 2024
Study start20 Nov 2024 (estimated)
Primary completion20 May 2026 (estimated)
Study completion20 Nov 2026 (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 Ruijin HospitalThe 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: 27 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06697366
Sponsor's protocol ID: 24-OBU-SH-GC-Ⅱ-013
Status last verified: Nov 2024
First submitted: 14 Nov 2024
Last updated: 20 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The researchers decided not to share

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Liposomal Irinotecan in Combination with Sintilimab in Second-Line Treatment of Progressive Gastric Cancer, a Single-Arm, Single-Center, Open-Label, Phase II Clinical Study
ClinicalTrials.gov ID: NCT06697366
Acronym / sponsor ID: 24-OBU-SH-GC-Ⅱ-013
Conditions: Gastric Cancer
Keywords: gastric cancer, irinotecan liposome, Sintilimab, second-line treatment
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 27 participants (estimated)
Lead sponsor: Ruijin HospitalUniversity, hospital or other
Study start: 20 Nov 2024 (estimated)
Primary completion: 20 May 2026 (estimated)
Study completion: 20 Nov 2026 (estimated)
First posted: 20 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.

Evaluating the efficacy and safety of irinotecan liposome injection in combination with Sintilimab in the second-line treatment of progressive gastric cancer

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
treatment	Experimental	Drug: Irinotecan liposome injection Ⅱ, Drug: SintilimabThe patients with Progressive Stage Gastric Cancer will be enrolled and given Sintilimab: 200 mg over 1 hour IV, given every 3 weeks. Irinotecan Liposome Injection II: 56.6 mg/m2 (free base) every 3 weeks, depending on the dose. Sequence of administration: Sindilizumab and Irinotecan Liposome Injection II will be given sequentially. Pre-treatment medication: Dexamethasone and antiemetic (or prophylactic irinotecan if preferred according to hospital practice).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

Age 18-75 years old, gender is not limited;
Pathologically confirmed adenocarcinoma (originating from the stomach and gastroesophageal junction);
Clinical documentation of failure of prior standard therapy (treatment with at least 1 cycle of standard chemotherapy regimen, disease progression or intolerance during treatment, or disease progression after completion of treatment).
An Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 2;
Have equivalent organ function, i.e., meet the following criteria:

Key exclusion criteria (11 listed)

Patients previously treated with irinotecan;
Subjects with ascites requiring clinical intervention (including subjects with moderate to large amounts of ascites, if the subject's ascites needs to be stabilized for more than 4 weeks after drainage);
Clinically significant gastrointestinal-like illness (including bleeding, infectious inflammation, perforation, obstruction, or diarrhea greater than grade 1);
second primary malignant tumor within 5 years (except for cured carcinoma in situ, basal or squamous cell skin cancer; subjects with other previous neoplasms that have not recurred within 5 years may be enrolled);
Suffering from uncontrolled cardiac or cerebral diseases or clinical symptoms, including but not limited to: ① NYHA class III or higher heart failure; ② unstable angina; ③ myocardial infarction or stroke within 6 months; ④ supraventricular or ventricular arrhythmia requiring treatment or intervention; ⑤ uncontrollable hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg after optimal treatment) ;

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 liposome injection Ⅱ56.6 mg/m2，Q3W	Drug	treatment
Sintilimab200mg，Q3W	Drug	treatment

Primary outcome

overall response rate,ORR
Time frame: up to two years
the best response rate

3 secondary outcomes

progression free survival,PFS
Time frame: up to two years
Disease control rate,DCR
Time frame: up to two years
adverse events, AE
Time frame: up to two 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 20 Nov 2024.
Individual participant dataSharing planned: No. The researchers decided not to share

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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.

Hao Li, MD, PhD contact

15000660260

lh11001@rjh.com.cn

Hao Li principal investigator

Ruijin Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan liposome injection Ⅱ and Sintilimab in people with Gastric Cancer, run by Ruijin Hospital.

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 21 inclusion and 11 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

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 Hao Li, MD, PhD (15000660260, lh11001@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate,ORR (time frame: up to two years). 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 NCT06697366.

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 20 Nov 2024.