IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer (NCT07722494) | Clinical Trial Compass
RecruitingPhase 3
IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer
China550 participantsStarted 2026-07-31
Plain-language summary
This is an open-label, multicenter Phase 3 study to evaluate the safety and tolerability of IBI363 plus bevacizumab in patients with advanced colorectal cancer refractory or intolerant to standard-of-care therapy
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
. Has signed the written Informed Consent Form and is capable of complying with the visit schedules and relevant procedures specified in the protocol.
. Aged ≥ 18 years, with no restriction on gender.
. Histologically or cytologically confirmed unresectable metastatic colorectal adenocarcinoma.
. Has experienced treatment failure or intolerance to prior systemic standard therapies administered for metastatic disease, with failure or intolerance occurring on the most recent line of systemic therapy.
. Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
. Colorectal cancer characterized by proficient mismatch repair (pMMR), or microsatellite stable (MSS) status.
. Confirmed adequate bone marrow and organ function at screening.
. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
Exclusion criteria
. Prior disease progression, treatment intolerance, or contraindication to all three agents: fruquintinib, trifluridine/tipiracil (TAS-102), and regorafenib.
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
Overall survival (OS)
Timeframe: Through out the study (an average of 2 years)
. Prior receipt of immunotherapy targeting anti-PD-(L)-1 or PD-L2 in the metastatic setting.
. History of severe toxicities related to anti-PD-(L)-1 immunotherapy or anti-VEGF therapy that necessitated permanent discontinuation of treatment, or contraindication to any of the above agents.
. Prior administration of interleukin (IL)-2 or IL-15 cytokines.
. Absence of documented clear evidence to confirm left- or right-sided primary colorectal tumor; or presence of primary colorectal lesions on both sides.
. Radiologically confirmed active or symptomatic central nervous system (CNS) metastases, including intraparenchymal brain, leptomeningeal, and spinal cord metastases.
. Subjects with unresolved adverse events attributable to any prior anti-tumor therapy that have not recovered to NCI CTCAE (Version 5.0) Grade 0 or Grade 1, or returned to baseline levels prior to randomization. Exceptions include alopecia, fatigue, hypothyroidism managed solely with thyroid hormone replacement, hyperglycemia controlled exclusively by insulin replacement, electrolyte abnormalities manageable with symptomatic treatment only, and other conditions judged by the Investigator to pose no safety risks with study drug administration.
. History of another malignant tumor within 5 years before the first dose of study drug. The following malignancies are allowed if curatively resected, with no current evidence of residual or recurrent disease and an extremely low recurrence risk: carcinoma in situ, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, lentigo maligna, localized prostate cancer, papillary thyroid carcinoma, non-invasive papillary urothelial carcinoma.