First-line Apatinib Combined With Tislelizumab and Chemotherapy for Advanced GC (NCT06238752) | Clinical Trial Compass
CompletedPhase 2
First-line Apatinib Combined With Tislelizumab and Chemotherapy for Advanced GC
China33 participantsStarted 2021-03-01
Plain-language summary
In this clinical study, investigators explore the efficacy and safety of a combination therapy regimen with antiangiogenic agent (apatinib), ICI (tislelizumab), and chemotherapy (capecitabine+ Oxaliplatin, XELOX) as first-line treatment for HER2-negative, advanced G/GEJ cancer patients with signet ring cell carcinoma or peritoneal metastasis.
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
. Sex: Men and women
. Age (at the time of informed consent): 18 years and older
. Patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been istologically confirmed to be adenocarcinoma and has not been treated with the first-line therapy with systemic antitumor agents for advanced or recurrent gastric cancer (including esophagogastric junction cancer).For patients who have received neoadjuvant or adjuvant chemotherapy (including chemoradiotherapy) in combination with curative or endoscopic surgery (R0 resection confirmed), the chemotherapy in the last regimen must be completed by at least 180 days before the date of recurrence.
. Have at least one measurable lesion, as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1), on computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days before enrolled in the study
. Able to provide tumor tissue specimens (archival or fresh biopsy specimens) for PD-L1 expression analysis. For patients who are unable to undergo another biopsy, archival specimens may be used as an alternative.
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.
What they're measuring
1
PFS
Timeframe: through study completion, an average of 1 year
. Have latest laboratory data meeting the criteria below within 7 days before enrolled. If the date of the laboratory tests at enrolled is not within 7 days before the first dose of the therapy regimen, testing should be repeated within 7 days before the first dose of the therapy regimen, and the latest laboratory data before the first dose of the therapy regimen must be confirmed to meet the following criteria. Moreover, laboratory data will not be valid if the patient has received a granulocyte colony stimulating factor (G-CSF) or blood transfusion within 14 days before testing.
Exclusion criteria
. Patients with HER2-positive or indeterminate gastric cancer (Determination for positive is made on the basis of the reference in each site. If there is no reference, rough indication for positive is 3+ by immunohistochemistry \[IHC\], or 2+ by IHC and positive by in situ hybridization \[ISH\]).
. multiple cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, and superficial bladder cancer, and any other cancers that have not recurred for at least 5 years)
. previous treatment with ICIs, chemotherapy or anti-angiogenic drug
. interstitial lung disease or pulmonary fibrosis
. Have concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease. Patients with Type 1 diabetes mellitus, hypothyroidism which is manageable by hormone replacement or skin disorders not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia) are permitted to be enrolled.
. Unable to take oral medicines
. Have a current or past history of severe hypersensitivity to any other antibody products
. Have concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease