Last updated: August 27, 2021
Sponsor: Jiangsu Cancer Institute & Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Colorectal Cancer
Treatment
N/AClinical Study ID
NCT04324476
JS-GI1902
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18-75 years old;
- Patients with advanced colorectal adenocarcinoma diagnosed by histopathology, or withmetastasis more than 12 months after radical operation, and the metastasis could notbe removed;
- ECOG score ≤ 2, estimated survival time ≥ 3 months;
- Leucocytes ≥ 3.5 × 109 / L, neutrophils ≥ 1.5 × 109 / L, hemoglobin ≥ 100g / L,platelets ≥ 80 × 109 / L, serum liver enzyme in patients without liver metastasis isnot higher than 2.5 times of the upper limit of normal value, serum liver enzyme inpatients with liver metastasis is not higher than 5 times of the upper limit of normalvalue, serum bilirubin level is not higher than 1.5 times of the upper limit of normalvalue, serum creatinine level is not higher than 1.5 times of the upper limit ofnormal value;
- At least one lesion can be measured by CT or MRI;
- No other history of malignant tumor;
- Those who are fertile but willing to take contraceptive measures;
- Sign the written informed consent.
Exclusion
Exclusion Criteria:
- Patients with allergic, hypersensitive constitution and autoimmune diseases;
- There are only unmeasurable lesions, such as hydrothorax and ascites, carcinomatouslymphangitis, diffuse liver invasion and bone metastasis; No measurable or nonassessable lesions;
- Pregnant or lactated women;
- Uncontrolled symptomatic brain metastasis or mental disorder can not correctlydescribe subjective symptoms;
- Major organ failure;
- Affecting drug administration, absorption, distribution, metabolism, excretion, etc.the patient has uncontrollable epileptic attack, central nervous system disorder orloss of self-knowledge due to mental disease, physiological or pathologicalmalnutrition, chronic diarrhea, and cachexia;
- Patients with complete or incomplete ileus;
- Patients with serious heart disease or history, including documented history ofcongestive heart failure, high-risk uncontrolled heart rate disorder, angina requiringdrug treatment, clinically clear history of heart valve disease, serious myocardialinfarction and stubborn hypertension;
- Severe uncontrollable infection;
- Alcohol and /or drug abuse or poor compliance of the investigator's judgment.
Study Design
Total Participants: 50
Study Start date:
September 01, 2019
Estimated Completion Date:
June 30, 2023
Study Description
Connect with a study center
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu 210009
ChinaActive - Recruiting
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