RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer (NCT06492317) | Clinical Trial Compass
Not Yet RecruitingPhase 2
RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer
China20 participantsStarted 2024-07-06
Plain-language summary
A single-arm, single-center phase II trial study to assess the efficacy and safety of disitamab vedotin plus cadonilimab as first-line therapy for HER2-overexpressing advanced stomach carcinoma
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
. Age: more than 18 years, gender is not limited;
. Confirmed locally advanced or distant metastasis gastric or gastroesophageal junction adenocarcinoma that is inoperable by pathological examination;
. Confirmed HER2 2+or 3+ by immunohistochemistry (IHC);
. At least 1 measurable lesion as determined by RECIST 1.1;
. There is no prior systematic treatment, or the patient has received neoadjuvant/adjuvant chemotherapy, and the disease progresses or relapses more than 6 months after the treatment;
. Eastern Cooperative Oncology Group (ECOG)performance status of 0-1;
. Adequate organ function:
. Bone marrow function: Hemoglobin count (HGB)≥80g/L;
Exclusion criteria
. Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drugs;
. Uncontrollable cardiovascular and cerebrovascular events , such as:
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: 6 months after the last subject participating in
Trial details
NCT IDNCT06492317
SponsorThe First Affiliated Hospital of Zhengzhou University
. Myocardial infarction occurred within 12 months;
. Supraventricular or ventricular arrhythmia with clinical significance needs treatment or intervention;
. Cerebral hemorrhage and cerebral infarction (except for lacunar cerebral infarction without symptoms and without treatment);
. Serious cardiovascular and cerebrovascular events occurred within 12 months; Uncontrolled hypertension, i.e. systolic blood pressure\>140 mmHg or diastolic blood pressure\>90 mmHg after treatment;