Neoadjuvant Toripalimab for dMMR/MSI-H Gastric Cancer (NCT05994456) | Clinical Trial Compass
UnknownPhase 2
Neoadjuvant Toripalimab for dMMR/MSI-H Gastric Cancer
China24 participantsStarted 2023-03-09
Plain-language summary
This is a single-center, open phase II clinical trial to evaluate the tolerability, safety and efficacy of toriparib monotherapy in the treatment of locally advanced dMMR/MSI-H gastric or gastroesophageal junction adenocarcinoma.
Who can participate
Age range
18 Years – 75 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
. Platelet (PLT) count ≥ 90\*109/L.
. Neutrophil count (ANC) ≥ 1.5\*109/L.
. Hemoglobin (Hb) level ≥ 9.0 g/dl.
. International normalized ratio (INR) ≤ 1.5.
. Prothrombin time (PT) and active partial thromboplastin time (APTT) ≤ 1.5 x ULN.
. Glycated hemoglobin (HbA1c) \<7.5%.
. Total bilirubin (TBIL) level ≤ 1.5 times the upper limit of normal (ULN).
. Alanine amino transaminase (ALT) and aspartate amino transaminase (AST) levels ≤ 2.5 x ULN.
Exclusion criteria
. Previously received chemotherapy, radiotherapy or immunotherapy for gastric cancer
. Previously diagnosed any other malignancy with a primary site or histological type different from gastric cancer within 5 years prior to study entry, except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
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.
. With known hypersensitivity to the study drug or excipients, or to similar drugs
. Received major surgery or open biopsy, or had a major trauma within 4 weeks prior to the start of study treatment
. Received immunosuppressive drugs (excluding inhaled corticosteroids or ≤10 mg/day prednisone or equivalent pharmacophysiologic doses of other systemic steroids) within 2 weeks prior to the start of study treatment
. Planned live attenuated vaccination within 4 weeks prior to the start of study treatment or during the study period
. Inability to discontinue CYP3A4 inducers or inhibitors within 1 week prior to the start of study treatment and during the study period
. Presence of any autoimmune disease or history of autoimmune disease.