Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or L… (NCT04263870) | Clinical Trial Compass
UnknownPhase 2
Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or Limited Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
China36 participantsStarted 2020-03
Plain-language summary
This study aims to evaluate the efficacy and safety of Sintilimab plus CAPOX in the conversion therapy for patients with unresectable locally advanced or limited metastatic adenocarcinoma of the stomach or esophagogastric junction
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
. Histologic and/or cytologic diagnosis of unresectable locally advanced or limited metastatic adenocarcinoma of the stomach or esophagogastric junction.
. Metastatic lesions are resectable or can be controlled by local ablative procedure.
. Definition of limited metastatic status:
. abdominal, retroperitoneallymphnodemetastases only (eg,para-aortic, intra aortic-caval, peripancreatic, or mesenterial lymph nodes).
. One incurable organ site with or without retroperitoneal lymph node metastases. One incurable organ site metastases according to the following schema： - Localized potentially operable peritoneal carcinomatosis or only cytology- positive (Cy1) peritoneal lavage fluid without macroscopic peritoneal metastasis .
. Tumor HER-2 is negative.
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.
.Severe hepatorenal insufficiency or history of myocardial infarction (within 3 months).
.5-year history of other malignancies(except skin basal cell carcinoma, cervical carcinoma in situ).
.Subjects with active or previous autoimmune diseases or risks that may recur(eg：requiring immunosuppressive therapy for organ transplantation). However, subjects with type I diabetes, hypothyroidism requiring hormone replacement therapy only, or skin diseases without systemic treatment (such as vitiligo, psoriasis, or alopecia) were allowed to enter the group.
.Have had interstitial lung disease or noninfective pneumonia, etc. symptoms of the disease or previous lung history may hinder the assessment or management of lung toxicity related to the study drug.
.Before the first administration of the study drug and who had a history of active tuberculosis infection more than one year ago were considered suitable for inclusion if they were judged by the investigator to have no evidence of active tuberculosis at present.
.Severe uncontrolled medical disease or acute infection (fever above 38 ℃ caused by infection).
.The combination of serious internal and external diseases, affecting organ function, the researchers think it is not suitable to participate in this clinical trial.
.Pregnant or lactating women or fertile (men or women with menopause less than 1 year) are unwilling to take contraceptive measures.