NCT06356714 Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens for the Treatment of Potentially Hazardous Colorectal Cancer SD Status
| NCT ID | NCT06356714 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Jing |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2025-03-15 |
| Primary Completion | 2026-09-24 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: 1. Age ≥ 18 years old, gender is not limited; 2. Colorectal adenocarcinoma confirmed by pathologic histology and/or cytology and imaging; 3. Have 1 or more measurable lesions with a longest diameter of at least 10 mm as determined by spiral CT scanning; and a diameter of at least 20 mm as determined by conventional CT scanning (Criteria for the Evaluation of Efficacy in Solid Tumors, i.e., RECIST Criteria, version 1.1); 4. Prior second- or third-line therapy for advanced or metastatic colorectal cancer with potentially harmful SD status. The potentially hazardous SD (Stable Disease) state is defined as an increase in SLD (Sum of Longest Diameters) by less than 20% according to RECIST 1.1 criteria, with an absolute increase of SLD ≤ 5mm from the nadir; a serum CEA (Carcinoembryonic Antigen) level below 10.0 ng/ml during stable disease, with two consecutive measurements of 10 ng/ml or more (with a testing interval of at least one month); or a serum CEA level of 10 ng/
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