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New treatment option for Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Official title Clinical Study of Low-dose Interval Radiotherapy Combined With Tirelizumab and SOX Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT06766578
What this study is testing
What is Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1)?
Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1) is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for locally advanced gastric/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
- To evaluate the initial efficacy and safety of neoadjuvant low-dose interval radiotherapy combined with tirelizumab and SOX chemotherapy in locally advanced gastric/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 75
You may be able to join if
- Patients voluntarily participated in the study and signed informed consent with good compliance and follow-up;
- Adenocarcinoma of the gastric/gastroesophageal junction confirmed by endoscopic pathology (tumor located in the lesser bend of the stomach other than...
- Patients with cT4N+M0 AJCC stage 8 combined with endoscopic, CT, MRI, or PETCT findings;
- Age ≥18 years, ≤75 years, male and female;
- ECOG PS score 0-1;
You likely can't join if
- a history of surgery for gastric/esophagogastric junction tumors;
- Previous history of fistula caused by primary tumor invasion;
- Higher risk of gastrointestinal bleeding and perforation;
- Poor nutritional status, BMI less than 18.5kg/m2, or PG-SGA score ≥9;
- Major surgery or severe trauma within 4 weeks prior to first use of the study drug;
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
See the full eligibility criteria
- Patients voluntarily participated in the study and signed informed consent with good compliance and follow-up;
- Adenocarcinoma of the gastric/gastroesophageal junction confirmed by endoscopic pathology (tumor located in the lesser bend of the stomach other than pylorus or the gastroesophageal junction) (Note: Pathology in other...
- Patients with cT4N+M0 AJCC stage 8 combined with endoscopic, CT, MRI, or PETCT findings;
- Age ≥18 years, ≤75 years, male and female;
- ECOG PS score 0-1;
- Presence of measurable and/or unmeasurable lesions as defined by the how well it works evaluation criteria for solid tumors (Recist 1.1);
- Has not received any prior systemic antitumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted drug therapy, immunotherapy, biotherapy, topical therapy, or other...
- The functions of vital organs meet the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before screening) : Neutrophil absolute count (ANC) ≥ 1.5×10 9/L; Platelets...
- Fertile female people shall perform a urine or serum pregnancy test within 72 hours prior to receiving the first study drug, prove negative, and be willing to use an effective method of contraception during the trial...
- a history of surgery for gastric/esophagogastric junction tumors;
- Previous history of fistula caused by primary tumor invasion;
- Higher risk of gastrointestinal bleeding and perforation;
- Poor nutritional status, BMI less than 18.5kg/m2, or PG-SGA score ≥9;
- Major surgery or severe trauma within 4 weeks prior to first use of the study drug;
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- has received or is currently receiving any of the following previous treatments: anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted therapy;
- Received any investigational drug within 4 weeks prior to first use of the investigational drug;
- people requiring systemic treatment with corticosteroids (\> 10mg prednisone equivalent daily dose) or other immunosuppressants within 2 weeks prior to initial use of the study drug, except for corticosteroids for...
- those who have received antitumor vaccine or have received live vaccine within 4 weeks prior to the first administration of the study drug;
- have any active autoimmune disease or a history of autoimmune disease (such as interstitial pulmonary inflammation, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism...
- have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation;
- any condition requiring systemic treatment with corticosteroids (more than 10 mg/ day of prednisone or its equivalent) or other immunosuppressant treatment within 14 days prior to treatment (except local, ocular...
- people with uncontrolled cardiac clinical symptoms or disease, such as (1) NYHA II or above heart failure (2) unstable angina pecina (3) myocardial infarction within 1 year (4) clinically significant ventricular...
- Severe infection (CTCAE \> level 2), such as severe pneumonia, bacteremia, and infectious complications requiring hospitalization, occurred within 4 weeks prior to initial use of the study drug; Chest imaging at...
- a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis or other uncontrolled acute lung disease;
- Patients with active pulmonary tuberculosis infection found by history or CT examination, or patients with active pulmonary tuberculosis infection history within 1 year before enrollment, or patients with active...
- people with active hepatitis B (HBV DNA≥2000 IU/mL or 10 4 Copies /mL), hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the lower limit of detection method);
- Abnormal values of sodium, potassium and calcium greater than grade 1 in laboratory tests within 2 weeks before enrollment, which could not be improved after treatment;
- known allergy to macromolecular protein preparations, or to any COMPONENT of PD-1, or allergy, hypersensitivity or contraindication to oxaliplatin or capecitabine or any component used in their preparations;
- A prior diagnosis of any other malignancy, other than malignancies with a low risk of metastasis and death (5-year survival \> 90%), such as adequately treated basal or squamous cell skin cancer or carcinoma in situ of...
- pregnant or lactating women; Fertile people unwilling or unable to use effective contraception;
- According to the investigator's judgment, people have other factors that may cause them to be forced to terminate the study, such as other serious diseases (including mental diseases) requiring combined treatment, other...
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, 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.