TACE Combined With Thermal Ablation and ADC, PD-1, and Chemotherapy as First-line Treatment for H… (NCT07602140) | Clinical Trial Compass
Not Yet RecruitingPhase 2
TACE Combined With Thermal Ablation and ADC, PD-1, and Chemotherapy as First-line Treatment for HER2-highly-expressing Gastric Cancer With Liver Metastases: A Multicenter, Single-arm Prospective Clinical Study.
40 participantsStarted 2026-08-01
Plain-language summary
This study is a multicenter, single-arm prospective clinical trial designed to evaluate the efficacy of TACE combined with thermal ablation, antibody-drug conjugates, immune checkpoint inhibitors, and first-line chemotherapy for the treatment of HER2 - highly expressing gastric cancer with liver metastases.
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
. Participants voluntarily joined this study, signed informed consent forms, demonstrated good compliance, and cooperated with follow-up.
. Male or female, aged 18 or older and 75 or younger;
. ECOG score is 0-1;
. Expected survival time ≥ 3 months;
. Imaging examinations suggest gastric cancer with liver metastasis;
. Histopathologically confirmed gastric adenocarcinoma and liver metastatic adenocarcinoma;
. Enhanced CT scans were used to observe the staining of liver metastases; tumors with good blood supply were included in this study.
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
Objective response rate (ORR)
Timeframe: Approximately 1 month after imaging examination
. Immunohistochemical results of gastric adenocarcinoma and/or liver metastatic adenocarcinoma confirmed high expression of HER2 (defined as: IHC 2+ or 3+);
Exclusion criteria
. diagnosed with other malignant tumors within 5 years prior to the first dose and who are not cured (excluding radically resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been radically removed);
. Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose;
. Previous treatment with the following: antibody-drug conjugates, anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co-inhibit T cell receptors (e.g. CTLA-4, OX-40, CD137);
. Within 28 days prior to the first administration of the study drug, the target lesion had received local treatment (including transarterial chemoembolization/TACE, hepatic artery infusion chemotherapy/TAC, radiotherapy, radioembolization or ablation, etc.);
. The patient had received systemic treatment with traditional Chinese medicine or immunomodulatory drugs with antitumor indications within 2 weeks prior to the first dose ;
. Subjects with any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or whose childhood asthma was completely remitted and requires no intervention in adulthood are eligible to be included; subjects with asthma requiring medical intervention with bronchodilators are not eligible to be included).
. Subjects are currently using immunosuppressants, or systemic or absorbable topical corticosteroids, to achieve immunosuppression (dose \>10 mg/ day prednisone or other equivalent corticosteroids), and have continued to use them within 2 weeks prior to enrollment; Note: Physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent drugs) are permitted.
. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;