RecruitingPhase 2interventionalRules rewrite

Phase 2: testing sintilimab+metronomic POLF for Gastric Cancer

To evaluate how well it works and safety of Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (POLF) in resectable locally advanced gastric cancer.

Official registry: https://clinicaltrials.gov/study/NCT06054906 · Huashan Hospital · enrollment listed as 50

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are sintilimab+metronomic POLF. The registry lists allocation as na. To evaluate how well it works and safety of Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (POLF) in resectable locally advanced gastric cancer.

They plan to enroll about 50 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (POLF) for Resectable Locally Advanced Gastric Cancer : A Phase Il Study

Interventions: sintilimab+metronomic POLF

Primary outcome (registry wording): Percentage of participants with no residual surviving tumor cells in resection specimens and lymph nodes

Who it is for (from inclusion criteria)

Ages 18 Years to any
Male or female, age ≥ 18 years old
Histologically confirmed gastric adenocarcinoma, diagnosed as locally progressive according to the AJCC 8th ed, cTNM diagnosis of cT3-4aN1-3M0 and resectable lesion as assessed by the investigator
No prior systemic therapy such as surgery, radiotherapy, or immunotherapy for the disease at hand
Consent to radical surgical treatment and no contraindications to surgery as determined by the surgeon
Expected survival \> 6 months
Adequate organ function, must meet the following laboratory specifications:
Negative pregnancy test in women of childbearing age

Who the registry excludes

Endoscopically show signs of active bleeding from the lesion
Current participation in an treatment clinical study or treatment with another investigational drug or use of an investigational device within 4 weeks prior to the first dose of study drug
Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or agents targeting CTLA-4, OX-40, CD137, etc
Diagnosis of a malignant disease other than gastric cancer within 5 years prior to the first dose of therapy
Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose of the drug
Live vaccination within 30 days prior to the first administration of the drug
Have received systemic systemic therapy with proprietary Chinese medicines with antitumor indications or immunomodulatory drugs within 2 weeks prior to the first administration of the drug

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

1 listed

Huashan Hospital, Fudan University — Shanghai, China (recruiting)

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FAQ about this NCT record

Is NCT06054906 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06054906?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06054906?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary