Chemotherapy-induced diarrhea
Conditions
Interventions
Part A 1:UA007 D1, 2, 3 + FOLFIRI
Part A 2:PBO D1 + UA007 D2, 3 + FOLFIRI
Part A 3:UA007 once daily for 3 days + FOLFIRI
Part A extension 1:UA007 + FOLFIRI
Part A extension 2:PBO + FOLFIRI
Part B 1:UA007 + FOLFIRI
Part B 2:PBO + FOLFIRI
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years (inclusive), gender is not limited; 2. ECOG score 0-1; 3. Diagnosed of colorectal cancer by histopathology; 4. The tumor is unresectable and requires a second-line chemotherapy regimen (Part A, PartA extension) or a first- or second-line chemotherapy regimen containing FOLFIRI. Estimated survival period >= 3 months; 5. Subject must have at least 1 assessable lesion according to RECIST v1.1 assessment; 6. The adverse reactions of previous anti-tumor therapy have returned to CTCAE 5.0 rating <= 1 (the investigators judged that there was no security risk is excluded, such as hair loss, grade 2 peripheral neurotoxicity, and stable hypothyroidism with hormone replacement therapy); 7. Fertile subjects (both male and female) must agree to do so during the trial and within at least 12 weeks after the last dose: with reliable methods of contraception (hormone or barrier method or abstinence); Fertile female subjects during the screening period whose blood or urine pregnancy test must be negative; 8. The subject can communicate well with the researcher and can complete the study in accordance with the research regulations; 9. Subjects must give informed consent to the study prior to the trial and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded: 1. History of malignancy other than colorectal cancer prior to randomization, the situation of no metastasis or death risk (as expected 5-year OS > 90%) is not included, malignancies that are expected to heal after treatment (e.g., adequate treatment of cervix carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer undergoing radical therapy, cancer in situ after radical surgery ) is not included; 2. History of receiving irinotecan chemotherapy; 3. Untreated or clinically symptomatic brain metastases, spinal cord compression, cancerous meningitis, or other evidence of the patient with brain and spinal cord metastases have not been controlled, and the researchers have judged that they are not suitable for admission; Have clinical symptoms are suspected of cerebral or leptomeningal diseaseThe patient needs further examination to be excluded; 4. History of severe cardiovascular disease: (1) Ventricular arrhythmias requiring clinical intervention; (2) Acute coronary syndrome, congestive heart failure, stroke, or other cardiovascular events of grade III or above within 6 months (if there is no history of atrial fibrillation with thrombosis, the investigator will comprehensively evaluate whether they can be enrolled); (3) The NYHA Cardiac Function Grade >= II or Left Ventricular Ejection Fraction (LVEF) 3xULN, AST > 3xULN or TBIL > 2xULN (for liver metastases: ALT > 5xULN, AST > 5xULN or TBIL > 3xULN); 9. Moderate to severe renal insufficiency: Cr > 1.5xULN or creatinine clearance = 200 ml (whole or component blood) within 4 weeks prior to randomization; 11. WBC 200 IU/ml or lower limit of research center detection [only if the lower limit of research center detection is higher than 200 IU/ml]); Active hepatitis C virus infection (positive anti-HCV antibody and hepatitis C virus RNA test higher than the lower limit of the research center test value); Human immunodeficiency virus (HIV) infection; Active syphilis infection (previously cured syphilis can be enrolled); 14. Uncontrolled infection, requiring intravenous antibiotics (or antiviral, antifungal drugs) treatment; 15. Received treatment with targeted IL-1/IL-1Ra/IL-1R within 4 weeks prior to randomization; 16. Received other clinical trial drugs within 4 weeks before randomization; 17. Received radiotherapy (except for local bone radiation therapy due to bone metastases), biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor therapy within 4 weeks prior to randomization, except for the following items: (1) Nitrosurea antineoplastic drugs or mitomycin C are randomized within 6 weeks prior to randomization; (2) Oral fluorouracils, small molec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of CID (chemotherapy induced diarrhea) in Cycle 1 to Cycle 3 that grade is >= 3; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of CID in Cycle 1 to Cycle 3 that grade is >= 2;Incidence rate of CID in Cycle1 that grade is >= 3;Incidence rate of CID in Cycle 1~Cycle 6 that grade is >= 3;Durable time of CID in Cycle 1~Cycle 6 that grade is >=3;Treatment of CID in Cycle 1~Cycle 3;Treatment of CID in Cycle 1~Cycle 6;Number of delaying and/or reducing of chemotherapy in Cycle 1~Cycle 6;Incidence rate of CIN (chemotherapy-induced neutropenia ) in Cycle 1~Cycle 6 that grade is >= 3;Incidence rate of CIN in Cycle 1 that grade is >= 3;The ratio of irinotecan maintaining the same chemotherapy dose and the original treatment time;Gastrointestinal function score in Cycle 1~Cycle 6;Incidence rate of SAE (Sever Adverse Event);Incidence rate of AE (Adverse Event) that grade is >= 3;immunogenicity;ORR, Objective Remission Rate;DCR, Disease Control Rate;Median Progression-Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactJin Li
Shanghai East Hospital
Outcome results
None listed