Gastric Cancer Stage IVPhase 1/2NCT05319639
Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab
A Phase 1/2 study testing Oxaliplatin, Levo-Leucovorin and 5-fluorouracil in people with Gastric Cancer Stage IV, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
The purpose of the phase I/II study is to establish the safety of Combination of Irinotecan and paclitaxel with 5-FU, leucovorin, oxaliplatin and Tislelizumab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer Stage IV
- What is being tested?
- Oxaliplatin, Levo-Leucovorin and 5-fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2023to 31 Dec 2025
- Phase
- Phase 1/2
- 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
- Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
- With or without measurable lesions.
- Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
- Life expectancy ≥3 months.
- With normal electrocardiogram results and no history of congestive heart failure.
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- With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
- Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of Tislelizumab until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug
- With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
- With good compliance and agree to accept follow-up of disease progression and adverse events.
Who cannot join
- Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
- Patients with brain or central nervous system metastases, including leptomeningeal disease.
- Pregnant (positive pregnancy test) or breast feeding.
- Serious, non-healing wound, ulcer, or bone fracture.
- Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
- History of a stroke or CVA within 6 months.
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- Clinically significant peripheral vascular disease.
- Inability to comply with study and/or follow-up procedures.
- Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
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, 1 recruiting
- Recruiting
Fujian cancer hospital
Fuzhou, Fujian, 350500
lin R bo, 13705919382 ext. 86, rongbo_lin@163.com
About this study
Official title: Phase I/II Study of the Combination of Irinotecan and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin) and Tislelizumab
The purpose of the phase I/II study is to establish the safety of Combination of Irinotecan and paclitaxel with 5-FU, leucovorin, oxaliplatin and Tislelizumab.
- Conditions
- Gastric Cancer Stage IV
- Being tested
- Oxaliplatin, Levo-Leucovorin, 5-fluorouracil, Paclitaxel, Irinotecan
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.
Levo-LeucovorinDrug
Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.
5-fluorouracilDrug
5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.
PaclitaxelDrug
Paclitaxel will be administered on day 1 of each cycle at 45mg/m2 at dose level 1; 67.5 mg/m2 at dose level 2 ; 90 mg/m2 at dose level 3; 112.5 mg/m2 at dose level 4 once every 14 days.
IrinotecanDrug
Irinotecan will be administered on day 1 of each cycle at 135 mg/m2 at dose level 1; 150 mg/m2 at dose level 2 once every 14 days.
TislelizumabDrug
Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.
| Study group | Role | What they receive |
|---|---|---|
| POFI and Tislelizumab | Experimental | This study will include a sequential evaluation of 3 subjects per cohort. Irinotecan 135 → 150 and paclitaxel 45 → 67.5 → 90 mg/m2 on day 1.
The rest of regimen is that oxaliplatin (85 mg/m2) and Lev-leucovolin (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. Tislelizumab 200mg，repeating the cycle every 14 days.
A dose limiting toxicity (DLT) event is defined as any of the following events in the first 4-week period:
CTCAE Grade 4 event (except for neutropenia lasting for ≤ 5 days); Grade 3 non-hematologic toxicity (except for nausea and vomiting that could be improved with optimal supportive care, escalation of alkaline phosphatase) If a DLT is experienced in any cohort, the cohort will be expanded to 6 subjects. If 2 DLTs are experienced in any cohort, the dose escalation ceased. The MTD was defined as the dose having at most two out of six patients experience DLT. Receives: Drug: Oxaliplatin; Drug: Levo-Leucovorin; Drug: 5-fluorouracil; Drug: Paclitaxel; Drug: Irinotecan; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum dose tolerated
To determine the maximum tolerated dose of POFI with different doses of irinotecan and paclitaxel combined with Tislelizumab in the first month.
Measured: 1 month
Secondary outcomes (3)
Overall Response Rate
Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).
Measured: 2 years
Progression-free survival
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
Measured: 2 years
Overall survival
The length of time from enrollment until the time of death (OS, overall survival).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start16 Feb 2023
- Primary completion31 Oct 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Fujian Cancer 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319639
- Sponsor's protocol ID
- SYLT-023
- Status last verified
- Jan 2025
- First submitted
- 1 Apr 2022
- Last updated
- 27 Feb 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of the Combination of Irinotecan and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin) and Tislelizumab
- ClinicalTrials.gov ID
- NCT05319639
- Acronym / sponsor ID
- SYLT-023
- Conditions
- Gastric Cancer Stage IV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Apr 2022 (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.
The purpose of the phase I/II study is to establish the safety of Combination of Irinotecan and paclitaxel with 5-FU, leucovorin, oxaliplatin and Tislelizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POFI and Tislelizumab | Experimental | Drug: Oxaliplatin, Drug: Levo-Leucovorin, Drug: 5-fluorouracil, Drug: Paclitaxel, Drug: Irinotecan, Drug: TislelizumabThis study will include a sequential evaluation of 3 subjects per cohort. Irinotecan 135 → 150 and paclitaxel 45 → 67.5 → 90 mg/m2 on day 1. The rest of regimen is that oxaliplatin (85 mg/m2) and Lev-leucovolin (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. Tislelizumab 200mg，repeating the cycle every 14 days. A dose limiting toxicity (DLT) event is defined as any of the following events in the first 4-week period: CTCAE Grade 4 event (except for neutropenia lasting for ≤ 5 days); Grade 3 non-hematologic toxicity (except for nausea and vomiting that could be improved with optimal supportive care, escalation of alkaline phosphatase) If a DLT is experienced in any cohort, the cohort will be expanded to 6 subjects. If 2 DLTs are experienced in any cohort, the dose escalation ceased. The MTD was defined as the dose having at most two out of six patients experience DLT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
- With or without measurable lesions.
- Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
- Life expectancy ≥3 months.
Key exclusion criteria (9 listed)
- Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
- Patients with brain or central nervous system metastases, including leptomeningeal disease.
- Pregnant (positive pregnancy test) or breast feeding.
- Serious, non-healing wound, ulcer, or bone fracture.
- Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
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 |
|---|---|---|
| OxaliplatinOxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days. | Drug | POFI and Tislelizumab |
| Levo-LeucovorinLevo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days. | Drug | POFI and Tislelizumab |
| 5-fluorouracil5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days. | Drug | POFI and Tislelizumab |
| PaclitaxelPaclitaxel will be administered on day 1 of each cycle at 45mg/m2 at dose level 1; 67.5 mg/m2 at dose level 2 ; 90 mg/m2 at dose level 3; 112.5 mg/m2 at dose level 4 once every 14 days. | Drug | POFI and Tislelizumab |
| IrinotecanIrinotecan will be administered on day 1 of each cycle at 135 mg/m2 at dose level 1; 150 mg/m2 at dose level 2 once every 14 days. | Drug | POFI and Tislelizumab |
| TislelizumabTislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days. | Drug | POFI and Tislelizumab |
Primary outcome
The maximum dose tolerated
Time frame: 1 month
To determine the maximum tolerated dose of POFI with different doses of irinotecan and paclitaxel combined with Tislelizumab in the first month.
3 secondary outcomes
Overall Response Rate
Time frame: 2 years
Progression-free survival
Time frame: 2 years
Overall survival
Time frame: 2 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 27 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oxaliplatin, Levo-Leucovorin and 5-fluorouracil in people with Gastric Cancer Stage IV, run by Fujian Cancer Hospital 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 9 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: looking for participants now, as of the sponsor's last update on 27 Feb 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 lin rong bo, bachelor (13705919382 ext. 86, rongbo_lin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum dose tolerated (time frame: 1 month). 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 27 Feb 2025.