Stomach NeoplasmsPhase 2NCT07819019

A Phase II Study of Irinotecan Liposome Plus Fruquintinib and Sintilimab in Second-Line PD-L1-Positive Advanced Gastric Cancer

A Phase 2 study testing Fruquintinib, Sintilimab and Irinotecan Hydrochloride Liposome Injection (II) in people with Stomach Neoplasms and Gastric Cancer, run by Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center.

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

English Translation (for ClinicalTrials.gov Patient-Friendly Summary): This is a Phase II clinical trial for patients with advanced gastric cancer (stomach cancer). We are looking for participants whose cancer has progressed after one prior standard chemotherapy regimen and whose tumors test positive for the PD-L1… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stomach Neoplasms, Gastric Cancer
What is being tested?: Fruquintinib, Sintilimab and Irinotecan Hydrochloride Liposome Injection (II)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: 1 Oct 2026to 1 Oct 2030
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who fully understand the study and voluntarily sign the informed consent form (ICF).
Age ≥ 18 years and ≤ 80 years.
Patients with histopathologically confirmed unresectable or metastatic gastric cancer, with positive PD-L1 expression (CPS ≥ 1).
Radiologically confirmed disease progression after prior first-line standard therapy.
At least one measurable target lesion according to RECIST 1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.

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Life expectancy ≥ 3 months.
Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 90 g/L (with no blood transfusion, no blood products, and no use of granulocyte colony-stimulating factor or other hematopoietic growth factors for correction within 14 days prior to laboratory testing).
Hepatic and renal function: serum creatinine ≤ 1.5 × the upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with liver metastases).
Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment, and must be willing to use appropriate contraception during the study and for 6 months after the last dose of study drug.

Who cannot join

Hypersensitivity to any study drug or its components.
Concurrent severe uncontrolled infection or other severe uncontrolled concomitant diseases, or moderate or severe renal impairment (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus, etc.).
Cardiac function and diseases meeting any of the following:
Long QT syndrome or QTc interval > 480 ms;
Complete left bundle branch block, or second- or third-degree atrioventricular block;
Severe uncontrolled arrhythmia requiring medication;

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New York Heart Association (NYHA) class ≥ III;
Left ventricular ejection fraction (LVEF) < 50%;
Myocardial infarction, unstable angina, history of severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically significant pericardial disease within 6 months prior to enrollment, or ECG evidence of acute ischemia or active conduction system abnormality.
Active hepatitis B or hepatitis C infection (hepatitis B surface antigen positive and hepatitis B virus DNA > 1 × 10^3 copies/mL; hepatitis C virus RNA > 1 × 10^3 copies/mL); asymptomatic chronic hepatitis B or hepatitis C carriers may be exempted.
Human immunodeficiency virus (HIV) infection (HIV antibody positive).
Radiologically confirmed intestinal obstruction.
History of or concurrent other malignancies (except adequately controlled non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment within the past five years).
Pregnant or lactating women, and patients of childbearing potential who are unwilling to use contraception.
Patients with other concurrent malignancies requiring treatment.
Patients judged by the investigator to be unsuitable for participation in this study.
History of pulmonary hemorrhage/hemoptysis ≥ grade 2 (defined as at least 2.5 mL of bright red blood) within 1 month prior to the first dose.
Arterial embolism, severe bleeding (excluding surgery-related bleeding), or severe bleeding tendency within 6 months prior to the first dose.
Symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, or spinal cord compression.
Use of strong inhibitors or inducers of CYP3A4, CYP2C8, or UGT1A1 within 14 days prior to study drug treatment.
Use of other investigational drugs within 1 month prior to the first dose.
Pregnant or lactating women, and subjects of childbearing potential who refuse contraception.

Trial locations and contacts

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

Junjie Hang contact

136 8170 9736

katerhjj0000@126.com

About this study

Official title: A Phase II Clinical Study of Irinotecan Liposome Combined With Fruquintinib and Sintilimab as Second-Line Therapy for PD-L1-Positive (CPS ≥ 1) Advanced Gastric Cancer

English Translation (for ClinicalTrials.gov Patient-Friendly Summary):

This is a Phase II clinical trial for patients with advanced gastric cancer (stomach cancer). We are looking for participants whose cancer has progressed after one prior standard chemotherapy regimen and whose tumors test positive for the PD-L1 protein.

This study is testing the effectiveness of a combination of three medications:

Irinotecan liposome: A chemotherapy drug wrapped in tiny fat particles (liposomes) to target tumors more precisely and minimize damage to healthy tissues.
Fruquintinib: An anti-angiogenic medication that blocks the growth of new blood vessels feeding the tumor, cutting off its nutrient supply.
Sintilimab: An immune checkpoint inhibitor that helps the body's own immune system recognize and attack cancer cells.

The primary goal of this study is to evaluate how well this three-drug combination works and to monitor its safety. Participants will receive the study drugs via intravenous infusion or oral tablets according to the protocol. Their progress will be tracked with CT scans and blood tests every three months. Regular follow-up visits will continue even after stopping treatment to monitor long-term outcomes.

Who can participate? Participants must be adults diagnosed with advanced gastric cancer who have progressed after only one prior first-line standard therapy, have PD-L1-positive tumors, and have no severe heart, liver, or kidney disease. Pregnant or breastfeeding women cannot participate.

Possible side effects Potential side effects may include nausea, vomiting, diarrhea, hand-foot swelling, low blood cell counts (which can increase infection risk), and fatigue. The research team will closely monitor all participants and provide prompt treatment for any side effects.

Important note This study is still in the clinical trial phase. While it offers a potential new treatment option beyond standard care, there is no guarantee that the drugs will be effective for every participant.

For more information, please contact the research team.

Conditions: Stomach Neoplasms, Gastric Cancer
Being tested: Fruquintinib, Sintilimab, Irinotecan Hydrochloride Liposome Injection (II)
Keywords: irinotecan hydrochloride liposome, gastric cancer
Medical subject headings: Stomach Neoplasms

What participants receive

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

FruquintinibDrug
3 mg orally once daily on days 1-7, followed by 7 days off (1 week on, 1 week off), in repeated cycles.
SintilimabBiological
200 mg administered by intravenous infusion on day 1 of each 21-day cycle.
Irinotecan Hydrochloride Liposome Injection (II)Drug
56.5 mg/m2 administered by intravenous infusion over 90 minutes on day 1 of each 14-day cycle.

Study groups in NCT07819019
Study group	Role	What they receive
Fruquintinib + Sintilimab + Liposomal Irinotecan	Experimental	Fruquintinib + Sintilimab + Liposomal Irinotecan Receives: Drug: Fruquintinib; Biological: Sintilimab; Drug: Irinotecan Hydrochloride Liposome Injection (II)

What is being measured

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

PFS
progression-free survival
Measured: From date of first dose until the date of first documented progression or death from any cause, whichever came first, assessed up to 12 months.

Secondary outcomes (4)

ORR
Objective Response Rate
Measured: Every 6 weeks from baseline until disease progression or initiation of subsequent anti-cancer therapy, assessed up to 12 months
DCR
Disease control rate
Measured: Every 6 weeks from baseline until disease progression, assessed up to 12 months
OS
Overall survival
Measured: From date of first dose until date of death from any cause, assessed up to 12 months.
Safety and Tolerability
Incidence, severity, and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs), graded according to CTCAE version 5.0, including AEs leading to dose delay, dose reduction, or treatment discontinuation.
Measured: From date of first dose through 30 days after last dose, assessed up to 13 months.

Timeline

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

1 Oct 20261 Oct 2030

First posted14 Sep 2026
Study start1 Oct 2026 (estimated)
Primary completion1 Oct 2028 (estimated)
Study completion1 Oct 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
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: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07819019
Sponsor's protocol ID: IFS-GC
Status last verified: Sep 2026
First submitted: 14 Aug 2026
Last updated: 14 Sep 2026
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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Clinical Study of Irinotecan Liposome Combined With Fruquintinib and Sintilimab as Second-Line Therapy for PD-L1-Positive (CPS ≥ 1) Advanced Gastric Cancer
ClinicalTrials.gov ID: NCT07819019
Acronym / sponsor ID: IFS-GC
Conditions: Stomach Neoplasms, Gastric Cancer
Keywords: irinotecan hydrochloride liposome, gastric cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 20 participants (estimated)
Lead sponsor: Cancer Hospital Chinese Academy of Medical Science, Shenzhen CenterUniversity, hospital or other
Collaborators: Shanghai Hengrui Pharmaceutical Co., Ltd.
Study start: 1 Oct 2026 (estimated)
Primary completion: 1 Oct 2028 (estimated)
Study completion: 1 Oct 2030 (estimated)
First posted: 14 Sep 2026 (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.

English Translation (for ClinicalTrials.gov Patient-Friendly Summary):

This study is testing the effectiveness of a combination of three medications:

Irinotecan liposome: A chemotherapy drug wrapped in tiny fat particles (liposomes) to target tumors more precisely and minimize damage to healthy tissues.
Fruquintinib: An anti-angiogenic medication that blocks the growth of new blood vessels feeding the tumor, cutting off its nutrient supply.
Sintilimab: An immune checkpoint inhibitor that helps the body's own immune system recognize and attack cancer cells.

For more information, please contact the research team.

Study design

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

Arm	Type	Receives
Fruquintinib + Sintilimab + Liposomal Irinotecan	Experimental	Drug: Fruquintinib, Biological: Sintilimab, Drug: Irinotecan Hydrochloride Liposome Injection (II)Fruquintinib + Sintilimab + Liposomal Irinotecan

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Patients who fully understand the study and voluntarily sign the informed consent form (ICF).
Age ≥ 18 years and ≤ 80 years.
Patients with histopathologically confirmed unresectable or metastatic gastric cancer, with positive PD-L1 expression (CPS ≥ 1).
Radiologically confirmed disease progression after prior first-line standard therapy.
At least one measurable target lesion according to RECIST 1.1 criteria.

Key exclusion criteria (22 listed)

Hypersensitivity to any study drug or its components.
Concurrent severe uncontrolled infection or other severe uncontrolled concomitant diseases, or moderate or severe renal impairment (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus, etc.).
Cardiac function and diseases meeting any of the following:
Active hepatitis B or hepatitis C infection (hepatitis B surface antigen positive and hepatitis B virus DNA > 1 × 10^3 copies/mL; hepatitis C virus RNA > 1 × 10^3 copies/mL); asymptomatic chronic hepatitis B or hepatitis C carriers may be exempted.
Human immunodeficiency virus (HIV) infection (HIV antibody positive).

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
Fruquintinib3 mg orally once daily on days 1-7, followed by 7 days off (1 week on, 1 week off), in repeated cycles.	Drug	Fruquintinib + Sintilimab + Liposomal Irinotecan
Sintilimab200 mg administered by intravenous infusion on day 1 of each 21-day cycle.	Biological	Fruquintinib + Sintilimab + Liposomal Irinotecan
Irinotecan Hydrochloride Liposome Injection (II)56.5 mg/m2 administered by intravenous infusion over 90 minutes on day 1 of each 14-day cycle.	Drug	Fruquintinib + Sintilimab + Liposomal Irinotecan

Primary outcome

PFS
Time frame: From date of first dose until the date of first documented progression or death from any cause, whichever came first, assessed up to 12 months.
progression-free survival

4 secondary outcomes

ORR
Time frame: Every 6 weeks from baseline until disease progression or initiation of subsequent anti-cancer therapy, assessed up to 12 months
DCR
Time frame: Every 6 weeks from baseline until disease progression, assessed up to 12 months
OS
Time frame: From date of first dose until date of death from any cause, assessed up to 12 months.
Safety and Tolerability
Time frame: From date of first dose through 30 days after last dose, assessed up to 13 months.

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 14 Sep 2026.
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.

Junjie Hang contact

136 8170 9736

katerhjj0000@126.com

Questions about this trial

What is this clinical trial studying?

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 22 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 14 Sep 2026. 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 Junjie Hang (136 8170 9736, katerhjj0000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: From date of first dose until the date of first documented progression or death from any cause, whichever came first, assessed up to 12 months.). 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 NCT07819019.

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 14 Sep 2026.