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Compares treatment options for Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Official title A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT07492615
What this study is testing
What is Sintilimab?
Sintilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer or gastroesophageal junction adenocarcinoma.
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
- This study aims to explore the efficacy and safety of sintilimab combined with SOX versus SOX alone as adjuvant therapy for patients with pIIIC stage or dMMR/MSI-H pIIIA/IIIB stage gastric/gastroesophageal junction adenocarcinoma. A total of 276 subjects are planned to be enrolled in this study.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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.
- Male or female, age ≥18 years.
- Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
- Diagnosed with pTNM stage IIIC or pTNM stage IIIA/IIIB.
- Diagnosed with mismatch repair deficiency (dMMR) by immunohistochemistry (IHC) of biopsy tissue or microsatellite instability-high (MSI-H) by genetic...
You likely can't join if
- Cancers involving the EGJ with the tumor center located in the proximal stomach ≤2 cm from the EGJ.
- Diagnosis of any other malignant disease other than gastric cancer within 5 years prior to first dose (excluding curatively treated basal cell...
- Currently participating in treatment clinical study treatment, or has received other investigational drugs or used investigational devices within 4...
- Prior receipt of the following therapies: anti-PD-1, anti-PD-L1, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including...
- Received systemic therapy with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferons...
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior...
See the full eligibility criteria
Who can join
- Signed written informed consent.
- Male or female, age ≥18 years.
- Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
- Diagnosed with pTNM stage IIIC or pTNM stage IIIA/IIIB.
- Diagnosed with mismatch repair deficiency (dMMR) by immunohistochemistry (IHC) of biopsy tissue or microsatellite instability-high (MSI-H) by genetic sequencing.
- Underwent D2 or more extensive radical resection and achieved R0 resection.
- Able to swallow tablets normally.
- ECOG performance status 0-1.
- Life expectancy \>6 months.
- Adequate organ function, people must meet the following laboratory criteria:
- Absolute neutrophil count (ANC) ≥1.5×10\^9/L without granulocyte colony-stimulating factor within the past 14 days.
- Platelets ≥100×10\^9/L without transfusion within the past 14 days.
- Hemoglobin \>9 g/dL without transfusion or erythropoietin use within the past 14 days.
- Total bilirubin ≤1.5×ULN; if total bilirubin \>1.5×ULN but direct bilirubin ≤ULN, enrollment is also permitted.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN.
- Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min.
- Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.
- Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal range. If baseline TSH is outside the normal range, people with total T3 (or FT3) and FT4 within the normal range may also be enrolled.
- Cardiac enzyme panel within normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are also permitted for enrollment).
- For female people of childbearing potential, a urine or serum pregnancy test must be negative within 3 days prior to the first dose of study drug (Cycle 1 Day 1). If the urine pregnancy test cannot be confirmed as...
- If at risk of conception, all people (male or female) must use contraceptive measures with a failure rate of \<1% per year throughout the treatment period and for 120 days after the last dose of study drug (or 180 days...
What rules you out
- Cancers involving the EGJ with the tumor center located in the proximal stomach ≤2 cm from the EGJ.
- Diagnosis of any other malignant disease other than gastric cancer within 5 years prior to first dose (excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or...
- Currently participating in treatment clinical study treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to first dose.
- Prior receipt of the following therapies: anti-PD-1, anti-PD-L1, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.).
- Received systemic therapy with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferons, interleukins, except for local use to control pleural effusion) within 2...
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to first dose. Replacement therapy (e.g., thyroxine, insulin, or...
- Receiving systemic corticosteroid therapy (excluding nasal spray, inhaled, or other topical corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to first dose.
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Known allergy to any drug used in this study.
- Has not adequately recovered from toxicities and/or complications caused by any prior intervention prior to starting treatment (i.e., ≤ grade 1 or returned to baseline, excluding fatigue or alopecia).
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive).
- Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number above the upper limit of normal of the testing laboratory at the study site). people meeting the following criteria may also be enrolled:
- HBV viral load \<1000 copies/ml (200 IU/ml) prior to first dose, people should receive anti-HBV therapy during the entire study chemotherapy treatment to prevent reactivation.
- For people with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is needed.
- people with active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection).
- Received a live vaccine within 30 days prior to first dose (Cycle 1, Day 1).
- Pregnant or breastfeeding women.
- Presence of any severe or uncontrolled systemic disease, such as:
- Abnormalities in resting ECG in rhythm, conduction, or morphology that are significant and severely symptomatic and difficult to control, such as complete left bundle branch block, second-degree or higher heart block...
- Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class ≥2.
- Any arterial thrombotic, embolic, or ischemic event within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
- Uncontrolled hypertension (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg).
- History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year prior to first dose, or current clinically active interstitial lung disease.
- Active pulmonary tuberculosis.
- Active or uncontrolled infection requiring systemic therapy.
- Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction.
- Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis.
- Poorly controlled diabetes (fasting blood glucose (FBG) \>10 mmol/L).
- Urinalysis indicates proteinuria ≥++ and confirmed 24-hour urine protein quantification \>1.0 g.
- Patients with mental disorders who are unable to comply with treatment.
- History or evidence of disease, treatment, or laboratory abnormalities that may interfere with the study results, hinder the subject's full participation in the study, or other conditions that the investigator deems...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, Shanghai Municipality, 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.