RecruitingPhase 2NCT06356714

Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens for the Treatment of Potentially Hazardous Colorectal Cancer SD Status

An Open Intervention Study of Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens for the Treatment of Potentially Hazardous Colorectal Cancer SD(Stable Disease) Status

Sponsor

Sun Jing

Enrollment

22 participants

Start Date

Mar 15, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Colorectal Neoplasms

Summary

Evaluate the efficacy and safety of Nocardia rubra cell wall skeleton in combination with prior second- or third-line regimens for the treatment of potentially hazardous colorectal cancer SD(Stable Disease) status in the real world.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding nocardia rubra cell wall skeleton (Nr-CWS) — an immune-stimulating agent derived from bacteria — to existing second- or third-line chemotherapy can stabilize colorectal cancer that appears to be slowly progressing. Eligible patients are those in a borderline "stable disease" state where cancer markers are creeping up. **You may be eligible if...** - You are 18 or older with confirmed colorectal adenocarcinoma that has spread - Your cancer is in a "borderline stable" state after second or third-line treatment — meaning it has not grown much, but cancer markers (CEA or CA19-9) are starting to rise - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You do not have measurable disease on imaging - Your cancer is clearly progressing (more than 20% growth) or clearly responding to treatment - You have had more than three prior lines of therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens

Nocardia Rubra Cell Wall Skeleton 200 mcg-400 mcg, 0.3 ml diluted in water for injection or lidocaine, was injected subcutaneously every 2 or 3 weeks. Efficacy was evaluated every 2 cycles according to RECIST 1.1 criteria. Patients are enrolled and given this study regimen of drugs on top of their prior second- or third-line regimen until disease progression or intolerable toxicities occur; or the patient requests to be discharged.