A Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study of SHR-A1811 in Combin… (NCT07676162) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal Cancer
China300 participantsStarted 2026-07
Plain-language summary
This study adopts a randomized, open-label, positive-controlled, multicenter design, aiming to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and bevacizumab versus standard therapy as first-line treatment for advanced colorectal cancer, and to explore the drug's immunogenicity and pharmacokinetic characteristics.
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
. Subjects voluntarily enroll in the study, sign informed consent, demonstrate good compliance and cooperate with follow-up visits.
. Aged between 18 and 75 years inclusive, male or female.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Estimated survival expectancy ≥ 12 weeks.
. Histologically or cytologically confirmed colorectal adenocarcinoma.
. No prior systemic anti-tumor therapy.
. Tumor tissue specimen must be provided, either archived within 1 year prior to first study treatment or newly collected fresh specimen.
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
Progression-Free Survival (PFS) assessed by the Independent Review Committee (IRC)
Timeframe: From the first dose to the last visit, approximately11 months
. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; the measurable lesion shall not have received prior local therapy such as radiotherapy.
Exclusion criteria
. Received systemic anti-tumor therapies (including investigational agents) or major surgery within 4 weeks prior to the first study drug administration; palliative radiotherapy within 2 weeks or surgery within 4 weeks before study treatment initiation.
. History of hypersensitivity to monoclonal antibodies or any component of the investigational products to be administered in this study.
. Pre-existing peripheral neuropathy of Grade \>1.
. History of thromboembolic disease within 6 months or hemoptysis within 3 months before first study medication. Subjects with muscular venous thrombosis not requiring anticoagulation per investigator's assessment are eligible for enrollment.
. CT/MRI evidence of tumor encasement or invasion of major blood vessels.
. Non-gastrointestinal bleeding within 6 months prior to first study drug administration, or active peptic ulcer disease.
. Uncontrolled hypertension, or medical history of hypertensive crisis or hypertensive encephalopathy.