Nocardia rubra cell wall skeleton added to prior second- or third-line therapy for potentially hazardous stable colorectal cancer

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

This test tries adding Nocardia rubra cell wall skeleton to prior second- or third-line treatments for adults with advanced colorectal cancer who have a potentially hazardous stable disease to see if it better controls their cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06356714 on ClinicalTrials.gov

What this trial studies

This is a prospective, phase 2 interventional trial giving Nocardia rubra cell wall skeleton alongside patients' prior second- or third-line regimens in a real-world setting. Eligible participants are adults with pathologically confirmed colorectal adenocarcinoma, at least one measurable lesion, and a defined ‘‘potentially hazardous’’ stable disease by RECIST 1.1 or rising tumor markers. The study monitors clinical efficacy (tumor measurements and marker trends) and safety while patients continue combination therapy. The trial is conducted at the First Affiliated Hospital of Nanjing Medical University and focuses on whether the addition improves disease control without unacceptable toxicity.

Who should consider this trial

Good fit: Adults (≥18) with pathologically confirmed colorectal adenocarcinoma who have received prior second- or third-line therapy, have at least one measurable lesion, and meet the study's definition of potentially hazardous stable disease are the intended candidates.

Not a fit: People who are treatment-naïve, who have clear progressive disease outside the trial's 'potentially hazardous SD' criteria, or who cannot attend the single study center are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, adding Nocardia rubra cell wall skeleton could improve tumor control or prolong stable disease for people with advanced colorectal cancer who have limited treatment options.

How similar studies have performed: While immunomodulatory agents like Nocardia rubra cell wall skeleton have shown preclinical activity and limited small clinical reports, robust randomized evidence for this approach in advanced colorectal cancer is scarce, so the combination remains relatively untested in large trials.

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/ml or more during stable disease, with a gradual increase in CEA after two consecutive measurements (with a testing interval of at least one month); a serum CA19-9 level below 60.0 ng/ml during stable disease, with two consecutive measurements of 60 ng/ml or more (with a testing interval of at least one month); or a serum CEA level of 60 ng/ml or more during stable disease, with a gradual increase in CEA after two consecutive measurements (with a testing interval of at least one month). Meeting any one of the above criteria can be considered as the presence of a potentially hazardous SD state.
5. The general condition score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1;
6. Expected survival ≧3 months;
7. Blood, liver and kidney function within 7 days prior to screening: absolute neutrophil count ≥ 1.5 x 109 /L; hemoglobin ≥ 9.0 g/dl; platelet count ≥ 100 x 109 /L; total bilirubin ≤ 1.5 times the upper limit of normal (ULN); gammaglutaminase and gammaglutaminase ≤ 3.0 x ULN (≤ 5 x ULN for patients with hepatic metastases); alkaline phosphatase ≤ 3 x ULN. phosphatase ≤ 3 x ULN (≤ 5 x ULN in patients with liver metastases); serum creatinine ≤ 1.5 x ULN;
8. Agreed to sign the informed consent form;

Exclusion Criteria:

1. Allergic constitution;
2. With comorbid diabetes;
3. Active clinically severe infection;
4. Any other conditions deemed exclusionary by the investigator.

Where this trial is running

Nanjing, Jiangsu

• the First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Jing Sun

Conditions Colorectal Cancer; Colorectal Neoplasms; Nocardia Rubra Cell Wall Skeleton