Gastric CancerPhase 2NCT07085273
Irinotecan Liposome II + 5-FU/LV + Oxaliplatin + Karelizumab in Neoadjuvant Treatment of Gastric Cancer
A Phase 2 study testing Irinotecan Liposomal in people with Gastric Cancer, run by The First Affiliated Hospital of Zhengzhou University.
Trial summary
For non-esophagogastric union progressive gastric cancer, the current treatment standard is D2 surgical resection combined with postoperative adjuvant chemotherapy, and for those with advanced stage (clinical stage III or above), perioperative chemotherapy mode can be chosen. 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 Liposomal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 30 Jun 2027
- 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 years and ≤ 75 years;
- gastric cancer confirmed by histopathology or cytology;
- critically resectable gastric cancer confirmed by imaging;
- at least one measurable lesion (according to RECIST v1.1);
- ECOG score of 0 to 2;
- expected survival time ≥ 3 months;
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- UGTA1*1*28 and UGTA1*1*6 genes tested wild-type;
- bone marrow function: neutrophils (ANC) ≥1.5×10^9/L, platelets (PLT) ≥100×10^9/L, hemoglobin (Hb) ≥90g/L, white blood cells (WBC) ≥3.0×10^9/L;
- Liver function: alanine aminotransferase (ALT), alanine transaminase (AST), alkaline phosphatase (ALP) ≤2.5×ULN (upper limit of normal), ≤5×ULN in case of liver metastasis; total bilirubin ≤1.5×ULN;
- renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 ml/min (calculated according to Cockroft-Gault), urine protein <2+;
- coagulation: international normalized ratio (INR) ≤ 1.5 times upper limit of normal (ULN) and activated partial thromboplastin time (APTT) ≤ 1.5 times upper limit of normal (ULN);
- be able to understand the circumstances of this study, and the patient and/or legal representative voluntarily agree to participate in this trial and sign the informed consent form.
Who cannot join
- patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and basal cell carcinoma of the skin);
- prior irinotecan/irinotecan liposome-based chemotherapy;
- large pleural effusions or ascites requiring intervention;
- active, uncontrolled bacterial, viral or fungal infections requiring systemic therapy
- known active HIV infection; untreated active HBV and HCV infection
- a combination of uncontrolled systemic diseases, including cardiovascular diseases such as unstable angina pectoris, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, and a history of severe pericardial disease; uncontrollable hypertension (defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after regulated antihypertensive medication) or a history of critical hypertension, hypertensive encephalopathy; uncontrollable diabetes; and controlled diabetes mellitus, etc;
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- the presence of severe gastrointestinal-like illness (including active bleeding, greater than grade 1 obstruction, greater than grade 1 diarrhea, or gastrointestinal perforation)
- history of cesarean section, open thoracic surgery or bowel resection within 28 days prior to enrollment;
- presence of interstitial pneumonia or pulmonary fibrosis;
- known hypersensitivity or intolerance to therapeutic drugs or their excipients;
- history of pulmonary hemorrhage/coughing up ≥ grade 2 (defined as at least 2.5 mL of bright red blood) within 1 month prior to enrollment;
- presence of arterial embolism, severe hemorrhage (other than hemorrhage due to surgery), or a predisposition to existing embolism or severe hemorrhage within 6 months prior to enrollment
- presence of central nervous system metastases;
- the presence of serum albumin ≤ 3 g/dL
- those using strong inhibitors or inducers of CYP3A4, CYP2C8 and UGT1A1;
- women who are pregnant or breastfeeding, and patients of childbearing potential who refuse to use adequate contraception during the course of this trial (from study enrollment to the end of primary study focus or surgical treatment);
- who have participated in another study within 30 days prior to the administration of the first dose of study drug
- patients who, in the judgment of the investigator, are not suitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm Clinical Study of Irinotecan Liposome II + 5-FU/LV + Oxaliplatin + Karelizumab for Neoadjuvant Treatment of Gastric Cancer
For non-esophagogastric union progressive gastric cancer, the current treatment standard is D2 surgical resection combined with postoperative adjuvant chemotherapy, and for those with advanced stage (clinical stage III or above), perioperative chemotherapy mode can be chosen. For progressive esophagogastric combination cancer, neoadjuvant radiotherapy or preoperative chemotherapy can be chosen. Preoperative chemotherapy significantly improves the tumor remission rate and R0 resection rate with good safety. Irinotecan has been widely used in clinical practice, and together with the available data from the Irinotecan Liposome (II) clinical study demonstrated good safety and clinical efficacy, bringing hope for prolonging progression-free survival and overall survival for several tumor patients. In order to further explore the safety and efficacy of the neoadjuvant therapeutic application of irinotecan liposome (II) in patients with gastric cancer, the present study was conducted to provide data to guide future clinical practice.
- Conditions
- Gastric Cancer
- Being tested
- Irinotecan Liposomal
- 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 LiposomalDrug
Also called 5-FU, Calcium folinate, Oxaliplatin, Karelizumab
FOLFIRINOX + Karelizumab Irinotecan liposomal: 60 mg/m2, IV infusion, d1; 5-FU: 400 mg/m2, IV infusion, d1, followed by 1200 mg/m2/d x 2 days of continuous IV infusion (total 2400 mg/m2, 46-48h infusion); Calcium folinate: 400 mg/m2, IV infusion, d1; Oxaliplatin: 85 mg/m2, IV infusion, d1; Karelizumab: 200 mg, IV infusion, d1; Repeat every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan liposomal+5-FU/Calcium folinate+Oxaliplatin+Karelizumab | Experimental | FOLFIRINOX + Karelizumab Irinotecan liposomal: 60 mg/m2, IV infusion, d1; 5-FU: 400 mg/m2, IV infusion, d1, followed by 1200 mg/m2/d x 2 days of continuous IV infusion (total 2400 mg/m2, 46-48h infusion); Calcium folinate: 400 mg/m2, IV infusion, d1; Oxaliplatin: 85 mg/m2, IV infusion, d1; Karelizumab: 200 mg, IV infusion, d1; Repeat every 2 weeks. Receives: Drug: Irinotecan Liposomal |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR
Rate of remission of major pathologies
Measured: After completion of 3 cycle of neoadjuvant therapy (through study completion, an average of half a year)
Secondary outcomes (2)
pCR
Pathologic complete remission rate
Measured: After completion of 3 cycle of neoadjuvant therapy (through study completion, an average of half a year)
R0 removal rate
R0 removal rate
Measured: After completion of 3 cycle of neoadjuvant therapy (through study completion, an average of half a year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 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 The First Affiliated Hospital of Zhengzhou 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongxu Jia, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085273
- Sponsor's protocol ID
- 25-OBU-HN-GC-II-012
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 31 Jul 2025
- 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Clinical Study of Irinotecan Liposome II + 5-FU/LV + Oxaliplatin + Karelizumab for Neoadjuvant Treatment of Gastric Cancer
- ClinicalTrials.gov ID
- NCT07085273
- Acronym / sponsor ID
- 25-OBU-HN-GC-II-012
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Jul 2025 (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.
For non-esophagogastric union progressive gastric cancer, the current treatment standard is D2 surgical resection combined with postoperative adjuvant chemotherapy, and for those with advanced stage (clinical stage III or above), perioperative chemotherapy mode can be chosen. For progressive esophagogastric combination cancer, neoadjuvant radiotherapy or preoperative chemotherapy can be chosen. Preoperative chemotherapy significantly improves the tumor remission rate and R0 resection rate with good safety. Irinotecan has been widely used in clinical practice, and together with the available data from the Irinotecan Liposome (II) clinical study demonstrated good safety and clinical efficacy, bringing hope for prolonging progression-free survival and overall survival for several tumor patients. In order to further explore the safety and efficacy of the neoadjuvant therapeutic application of irinotecan liposome (II) in patients with gastric cancer, the present study was conducted to provide data to guide future clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan liposomal+5-FU/Calcium folinate+Oxaliplatin+Karelizumab | Experimental | Drug: Irinotecan LiposomalFOLFIRINOX + Karelizumab Irinotecan liposomal: 60 mg/m2, IV infusion, d1; 5-FU: 400 mg/m2, IV infusion, d1, followed by 1200 mg/m2/d x 2 days of continuous IV infusion (total 2400 mg/m2, 46-48h infusion); Calcium folinate: 400 mg/m2, IV infusion, d1; Oxaliplatin: 85 mg/m2, IV infusion, d1; Karelizumab: 200 mg, IV infusion, d1; Repeat every 2 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- age ≥ 18 years and ≤ 75 years;
- gastric cancer confirmed by histopathology or cytology;
- critically resectable gastric cancer confirmed by imaging;
- at least one measurable lesion (according to RECIST v1.1);
- ECOG score of 0 to 2;
Key exclusion criteria (18 listed)
- patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and basal cell carcinoma of the skin);
- prior irinotecan/irinotecan liposome-based chemotherapy;
- large pleural effusions or ascites requiring intervention;
- active, uncontrolled bacterial, viral or fungal infections requiring systemic therapy
- known active HIV infection; untreated active HBV and HCV infection
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 LiposomalAlso: 5-FU, Calcium folinate, Oxaliplatin, KarelizumabFOLFIRINOX + Karelizumab Irinotecan liposomal: 60 mg/m2, IV infusion, d1; 5-FU: 400 mg/m2, IV infusion, d1, followed by 1200 mg/m2/d x 2 days of continuous IV infusion (total 2400 mg/m2, 46-48h infusion); Calcium folinate: 400 mg/m2, IV infusion, d1; Oxaliplatin: 85 mg/m2, IV infusion, d1; Karelizumab: 200 mg, IV infusion, d1; Repeat every 2 weeks. | Drug | Irinotecan liposomal+5-FU/Calcium folinate+Oxaliplatin+Karelizumab |
Primary outcome
MPR
Time frame: After completion of 3 cycle of neoadjuvant therapy (through study completion, an average of half a year)
Rate of remission of major pathologies
2 secondary outcomes
pCR
Time frame: After completion of 3 cycle of neoadjuvant therapy (through study completion, an average of half a year)
R0 removal rate
Time frame: After completion of 3 cycle of neoadjuvant therapy (through study completion, an average of half a year)
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 31 Jul 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan Liposomal in people with Gastric Cancer, run by The First Affiliated Hospital of Zhengzhou University.
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 18 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 31 Jul 2025. 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 Yongxu Jia, M.D. (15237128281, fccjiayx@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPR (time frame: After completion of 3 cycle of neoadjuvant therapy (through study completion, an average of half a year)). 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 31 Jul 2025.