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New treatment option for Gastric Cancer
Official title Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (PLOF) for Resectable Locally Advanced Gastric Cancer
ClinicalTrials.gov ID: NCT06054906
What this study is testing
What is sintilimab+metronomic PLOF?
sintilimab+metronomic PLOF is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate efficacy and safety of Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (PLOF) in resectable locally advanced gastric cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed written Informed Consent Form
- 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...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- Signed written Informed Consent Form
- 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
- ECOG PS: 0-1 score
- Expected survival \> 6 months
- Adequate organ function, must meet the following laboratory specifications: 8.1 Absolute neutrophil count (ANC) ≥ 1.0x10\^9/L; 8.2 Platelets ≥ 80x10\^9/L; 8.3 Hemoglobin \> 7g/dL; 8.4 Total bilirubin ≤ 1.5 x upper limit...
- Negative pregnancy test in women of childbearing age
- Need to use contraception with an annual failure rate of less than 1% if there is a risk of conception
- 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
- Have received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment
- Has not fully recovered from any intervention-induced toxicity and/or complications (excluding malaise or alopecia) prior to initiation of therapy
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
- Known hypersensitivity to drugs used in this study
- Known history of HIV infection
- Untreated active hepatitis B
- Active HCV infection
- Pregnant or lactating women
- The presence of any serious or uncontrolled systemic disease
- Other factors that, in the judgment of the investigator, may affect the outcome of the study
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.