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

NCT06356714 | Recruiting Phase 2

• 1 other identifier: 13914704179
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colorectal Neoplasms

Keywords

Nocardia Rubra Cell Wall Skeleton; Colorectal Cancer; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  Time between the start of a treatment regimen and tumor progression or death

  1 year

Secondary Outcomes (5)

• Overall survival (OS)

  2 year

• Objective remission rate (ORR)

  1 year

• Disease Control Rate (DCR)

  1 year

• Incidence and extent of major security incidents

  1 year

• Quality of Life Score (QoL) for tumor patients

  1 year

Study Arms (1)

Nocardia Rubra Cell Wall Skeleton +prior Second- or Third-line Regimens

EXPERIMENTAL

The patient has previously received second- or third-line treatment for advanced or metastatic colorectal cancer and has developed a potentially hazardous SD (Stable Disease) status. They will add to the original treatment regimen of Nocardia Rubra Cell Wall Skeleton.

Drug: Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens

Interventions

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

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.

Nocardia Rubra Cell Wall Skeleton +prior Second- or Third-line Regimens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, gender is not limited;
• Colorectal adenocarcinoma confirmed by pathologic histology and/or cytology and imaging;
• 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);
• 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.
• The general condition score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1;
• Expected survival ≧3 months;
• 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;
• Agreed to sign the informed consent form;

You may not qualify if:

• Allergic constitution;
• With comorbid diabetes;
• Active clinically severe infection;

Sponsors & Collaborators

• Sun Jing: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Jing Sun

CONTACT

13914704178; sunj@njmu.edu.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician、professor

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: March 15, 2025
• Primary Completion (Estimated): September 24, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)