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Trial Title:
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
Condition:
Colorectal Cancer
Colorectal Neoplasms
Conditions: Official terms:
Colorectal Neoplasms
Cell Wall Skeleton
Conditions: Keywords:
Nocardia Rubra Cell Wall Skeleton
Colorectal Cancer
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens
Description:
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.
Arm group label:
Nocardia Rubra Cell Wall Skeleton +prior Second- or Third-line Regimens
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.
Detailed description:
This is a prospective interventional clinical trial investigating 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.
Enrollment requirements were patients who had received prior second- or third-line
therapy for advanced or metastatic colorectal cancer and presented with a 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 1, 2024
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Sun Jing
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06356714
