Clinical trial · Interventional
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Colorectal Cancer
Phase Ⅱ,Open Label Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Colorectal Cancer
NCT01305980CI-TRIAL-00004508unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine efficacy of SB injection in Colorectal Cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SB injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluating Tumor Response Rate
- timeFrame
- 4 months
Secondary outcomes (3)
- measure
- Pain Scores on the Visual Analog Scale
- timeFrame
- 4 months
- measure
- evaluate patient's performance by measuring Eastern Cooperative Oncology Group scale
- timeFrame
- 4 months
- measure
- Determine duration of response rate by measuring time to progression
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age of 18years or over * Patients who had failed more than 1 cycle of standard therapy with advanced or metastatic stage and with measurable lesions * Life expectancy \>/= 5 months * Not available to any of resectable surgery or radiotherapy * Patients with adequate organ(e.g. heart, kidney, liver)and bone marrow function, as defined by 1. Absolute neutrophil count \>/= 1.0 x 10\^9/L, Platelet count \>/= 75 x 10\^9/L 2. Total bilirubin \< 2.0 mg/dL 3. Aspartate Aminotransferase and/or Aspartate Aminotransferase \< 5 x Upper Limit Normal 4. creatinine \< 2 x Upper Limit Normal * ECOG status 0 to 2 * Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7days ago * Patients or their legal representatives who have signed the informed consent form. Exclusion Criteria: * Have inflammatory bowel diseases * Have severe diarrhea or ileus * Previous total colectomy * Have ileostomy * Known brain or spinal cord metastases * Patients who have received chemotherapy within the previous 4 weeks * Patients who have received radiotherapy related tp colorectal cancer within 4weeks * Patients who have participated in other clinical study within the previous 4weeks * Pregnancy or lactation period * Human Immunodeficiency Virus antibody (+) * Have active infection or serious concomitant systemic disorder incompatible with the study * Clinically hypertension or diabetes mellitus not well controlled with medication * Clinically significant cardiac disease(congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction * Presence or history of malignancy other than colorectal cancer within 5years * Have severe Neurologic or psychological disorder * Patients who have history of allergy with this investigational drug(SB injection) * Obvious cognitive or physical impairment that would prevent participation
References
Publications (0)
Data not yet available
No reference posted for this study.