A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Ca… (NCT06074484) | Clinical Trial Compass
UnknownPhase 2
A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer
China36 participantsStarted 2023-09-10
Plain-language summary
This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with AK104 in perioperative treatment of muscle-invasive bladder cancer.
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:
* Voluntary agreement to provide written informed consent.
* Male or female, Age ≥ 18 years.
* Predicted survival ≥ 12 weeks.
* Histologically confirmed diagnosis of muscle invasive bladder cancer (MIBC) .Naive of antitumor systematic treatment or radiotherapy.
* Have clinically non-metastatic bladder cancer (cT2-T4a, N0-1, M0) determined by imaging. Voluntary agreement to provide written informed consent.
* Male or female, Age ≥ 18 years.
* Predicted survival ≥ 12 weeks.
* Histologically confirmed diagnosis of muscle invasive bladder cancer (MIBC).Naive of antitumor systematic treatment or radiotherapy.
* Have clinically non-metastatic bladder cancer (cT2-T4a, N0-1, M0) determined by imaging.
* Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
* HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment.
* Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
* Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
* Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
* HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab.
* Eastern Cooperative On…
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
Pathologic Complete Response (pCR) Rate
Timeframe: Up to approximately 16 Weeks (Time of surgery)
Trial details
NCT IDNCT06074484
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences