Gastric CancerPhase 3NCT06793917
Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced: a Multicenter, Open-label, Randomized Phase III Studyunresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
A Phase 3 study testing Tislelizumab, Oxaliplatin injection and Levo-Leucovorin in people with Gastric Cancer, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
To compare the efficacy and safety of tislelizumab combined with FOLFOX or combined with POF in the treatment of locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma with CPS≥1 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Tislelizumab, Oxaliplatin injection and Levo-Leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2025to 1 Apr 2029
- Phase
- Phase 3
- 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 70 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.
- 18-70yeas.
- ECOG PS 0-1.
- No previous chemotherapy (perioperative chemotherapy, six months after fluorouracil alone or one year after oxaliplatin or a combination of taxoid and fluorouracil can be included), radiotherapy or immunotherapy.
- 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.
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- With normal electrocardiogram results and no history of congestive heart failure.
- 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.
- Have a known PD-L1 CPS/MMR (or MSI) /HER2(FISH) test result, or have sufficient samples for relevant testing.
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.
- HIV-positive, active hepatitis B or C (HBV, HCV);
- 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.
- Her2-positive (IHC 3+ or 2+/FISH+) patients.
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 ron bo, bachelor
About this study
Official title: Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced Unresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
To compare the efficacy and safety of tislelizumab combined with FOLFOX or combined with POF in the treatment of locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma with CPS≥1
- Conditions
- Gastric Cancer
- Being tested
- Tislelizumab, Oxaliplatin injection, Levo-Leucovorin, 5-fluorouracil, Paclitaxel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.
Oxaliplatin injectionDrug
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 135mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with POF | Experimental | Not described Receives: Drug: Tislelizumab; Drug: Oxaliplatin injection; Drug: Levo-Leucovorin; Drug: 5-fluorouracil; Drug: Paclitaxel |
| Tislelizumab combined with mFOLFOX6 | Experimental | Not described Receives: Drug: Tislelizumab; Drug: Oxaliplatin injection; Drug: Levo-Leucovorin; Drug: 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival)
Measured: 4 years
Secondary outcomes (2)
Objective response rate
Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate)
Measured: every 4 weeks
Overall survival
The length of time from enrollment until the time of death (OS, overall survival).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start7 Jun 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2029 (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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 269 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rong bo Lin, bachelor, Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793917
- Sponsor's protocol ID
- SYLT-030
- Status last verified
- Jul 2025
- First submitted
- 21 Jan 2025
- Last updated
- 20 Jul 2025
- 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 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced Unresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06793917
- Acronym / sponsor ID
- SYLT-030
- Conditions
- Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 269 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 7 Jun 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 27 Jan 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.
To compare the efficacy and safety of tislelizumab combined with FOLFOX or combined with POF in the treatment of locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma with CPS≥1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab combined with POF | Experimental | Drug: Tislelizumab, Drug: Oxaliplatin injection, Drug: Levo-Leucovorin, Drug: 5-fluorouracil, Drug: Paclitaxel |
| Tislelizumab combined with mFOLFOX6 | Experimental | Drug: Tislelizumab, Drug: Oxaliplatin injection, Drug: Levo-Leucovorin, Drug: 5-fluorouracil |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
- 18-70yeas.
- ECOG PS 0-1.
- No previous chemotherapy (perioperative chemotherapy, six months after fluorouracil alone or one year after oxaliplatin or a combination of taxoid and fluorouracil can be included), radiotherapy or immunotherapy.
- 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.
Key exclusion criteria (11 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 |
|---|---|---|
| TislelizumabTislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days. | Drug | Tislelizumab combined with POF, Tislelizumab combined with mFOLFOX6 |
| Oxaliplatin injectionOxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days. | Drug | Tislelizumab combined with POF, Tislelizumab combined with mFOLFOX6 |
| Levo-LeucovorinLevo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days. | Drug | Tislelizumab combined with POF, Tislelizumab combined with mFOLFOX6 |
| 5-fluorouracil5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days. | Drug | Tislelizumab combined with POF, Tislelizumab combined with mFOLFOX6 |
| PaclitaxelPaclitaxel will be administered on day 1 of each cycle at 135mg/m2 | Drug | Tislelizumab combined with POF |
Primary outcome
progression free survival
Time frame: 4 years
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival)
2 secondary outcomes
Objective response rate
Time frame: every 4 weeks
Overall survival
Time frame: 4 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 Jul 2025.
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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.
Rong bo Lin, bachelor principal investigator
Fujian Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tislelizumab, Oxaliplatin injection and Levo-Leucovorin in people with Gastric Cancer, 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 11 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: looking for participants now, as of the sponsor's last update on 20 Jul 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Rong bo Lin, 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?
progression free survival (time frame: 4 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 20 Jul 2025.