A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy … (NCT07492615) | Clinical Trial Compass
RecruitingPhase 2
A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma
China276 participantsStarted 2026-01-29
Plain-language summary
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. Patients will be randomly assigned in a 1:1 ratio to receive up to 8 cycles of sintilimab combined with SOX or SOX alone as adjuvant therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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 curatively resected carcinoma in situ).
. Currently participating in interventional 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 weeks prior to first dose.
. 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 physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment.
. 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.