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New treatment option for Immune Suppression
Official title Nivolumab Combined With SOX Used in the Perioperative Treatment
ClinicalTrials.gov ID: NCT05739045
What this study is testing
What is nivolumab combined with SOX?
nivolumab combined with SOX is an investigational medicine, being studied as a potential treatment for immune suppression.
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 the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma;
- 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 to 80
You may be able to join if
- Patients must meet all of the following to be enrolled in the study: 1\. Patients voluntarily participate in the study and sign the informed consent...
- Blood routine examination criteria shall meet: (No blood transfusion or blood products within 14 days, no G-CSF or other hematopoietic stimulating...
- Criteria for biochemical tests: Total bilirubin \ 50 ml/min (males: Endogenous creatinine clearance rate = ((140-age) × body weight)/(72 × serum Cr)...
You likely can't join if
- Patients with any of the following are not to be enrolled in the study:
- Patients with unresectable factors, including unresectable tumor causes or unresectable surgical contraindications or refusal of surgery;
- Previous or concurrent other malignancy;
- Suffering from any chronic or major illness considered intolerable to treatment (eg, severe cardiac disease, uncontrolled hypertension, some degree...
- Patients who have previous gastrointestinal perforation, abdominal abscess or recent (within 3 months) intestinal obstruction or imaging and clinical...
- Patients having clinically significant bleeding symptoms or definite bleeding tendency within 3 months before the first dose of study drug, such as...
See the full eligibility criteria
- Patients must meet all of the following to be enrolled in the study: 1\. Patients voluntarily participate in the study and sign the informed consent form; 2. Age ≥ 18 years and ≤ 75 years; 3. Have pathologically...
- Blood routine examination criteria shall meet: (No blood transfusion or blood products within 14 days, no G-CSF or other hematopoietic stimulating factors are used for correction) Absolute neutrophil count ≥1.5×109/L...
- Criteria for biochemical tests: Total bilirubin \ 50 ml/min (males: Endogenous creatinine clearance rate = ((140-age) × body weight)/(72 × serum Cr); female: endogenous creatinine clearance rate = ((140-age) × body...
- Patients with any of the following are not to be enrolled in the study:
- Patients with unresectable factors, including unresectable tumor causes or unresectable surgical contraindications or refusal of surgery;
- Previous or concurrent other malignancy;
- Suffering from any chronic or major illness considered intolerable to treatment (eg, severe cardiac disease, uncontrolled hypertension, some degree of hepatic or renal dysfunction, etc.)
- Patients who have previous gastrointestinal perforation, abdominal abscess or recent (within 3 months) intestinal obstruction or imaging and clinical symptoms suggestive of intestinal obstruction;
- Patients having clinically significant bleeding symptoms or definite bleeding tendency within 3 months before the first dose of study drug, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or suffering from...
- Patients in the active stage of infection requiring treatment (such as antibacterial drugs, antiviral drugs, antifungal drugs);
- Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/ml; hepatitis C reference: HCV antibody positive and HCV viral copy number \> upper limit of normal);
- Patients with congenital or acquired immunodeficiency (such as HIV infection);
- Patients with any active autoimmune disease or history of autoimmune disease with potential relapse;
- Planned or previous organ or allogeneic bone marrow transplant;
- Patients with current interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring steroids, or people with active pneumonia or severe lung...
- Ongoing or recent treatment with immunosuppressive drugs or systemic corticosteroids to achieve immunosuppression;
- Patients who have received a live attenuated vaccine within 28 days prior to the first dose of study drug or who require administration of such vaccine during treatment or within 60 days after the last dose;
- Patients with known hypersensitivity to any of the study drugs or any of their excipients;
- Nursing mothers;
- Any factors that, in the judgment of the investigator, could affect patient safety and force the termination of the study
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.