Plain-English translation of NCT04547166 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This is a large clinical trial testing whether a new immunotherapy drug called serplulimab, when combined with two other standard cancer treatments (bevacizumab and chemotherapy), works better than the standard treatments alone for advanced colorectal cancer. The trial will include over 500 patients across multiple countries to compare the new medication plus standard treatment versus standard treatment alone. Roughly half of participants will receive the new medicine while the other half receives a placebo (dummy pill) alongside the standard treatments.
Advanced colorectal cancer is difficult to treat and many patients need better treatment options. This medication works by helping the immune system recognize and fight cancer cells, and researchers believe adding it to existing treatments might improve survival and slow cancer growth.
You likely qualify if…
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You will have a screening visit (up to 4 weeks) to confirm you are eligible, then begin treatment in 3-week cycles for up to 2 years. Each cycle involves receiving the study medication (either serplulimab or placebo) along with the standard chemotherapy and bevacizumab, typically through an IV infusion. You'll have regular clinic visits for monitoring, blood tests, and imaging scans to check how the cancer is responding. After treatment ends, you'll continue with follow-up appointments and safety checks, plus survival follow-up visits every 12 weeks to see how you are doing long-term.
AI-generated summary from trial data · Jun 6, 2026 · Not medical advice
China
Japan