Peripheral neuropathy
Conditions
Interventions
Experimental group:Trial drug TTYP01 tablets are to be administered the day before the planned start of the XELOX regimen (D0), 60 mg per dose, BID, PO, fasting, for a total of 8 cycles of XELOX regim
Sponsors
The First Affiliated Hospital of Nanyang Medical Specialized Higher School
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent form (ICF); 2. Age >=18 years and = 6 months; 5. Inclusion of patients with histologically and/or cytologically confirmed CRC who are proposed for adjuvant/neoadjuvant or late first-line treatment with 8 cycles of oxaliplatin in combination with capecitabine regimen (late first-line treatment may be acceptable in combination with bevacizumab); 6. Prior therapy needs to be free of neurotoxic drugs (e.g., paclitaxel or platinum, etc.); 7. Participants do not have a grade >=1 (NCI-CTCAE V5.0) CIPN; 8. Has adequate hematologic and organ function, as defined below, and has not been transfused with blood and blood products within 2 weeks prior to sampling for laboratory tests. (1). Hematologic system function: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelet (PLT) >= 100 × 10^9/L;Hemoglobin (HGB) >= 90 g/L; (2). Liver function: Total bilirubin (TBIL) = 50 mL/min; (4). Coagulation tests: International Normalized Ratio (INR) <=1.5 × ULN; Activated partial thromboplastin time (APTT) <= 1.5 x ULN Note: For participants receiving anticoagulant therapy, the investigator will determine if the INR and APTT are within safe therapeutic ranges. 9. female participants of childbearing potential (WOCBP), or male participants whose partner is a female of childbearing potential, agree to use effective contraception from the start of the Screening Period until 6 months after the last dose; 10. the participant is willing and able to comply with the visits, treatment regimens, laboratory tests, and other requirements of the study as specified in the schedule.
Exclusion criteria
Exclusion criteria: 1. participants with other malignancies within 3 years prior to enrollment, not excluding participants with other malignancies that have been cured by local therapy, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, and carcinoma in situ of the cervix or breast; 2. participants with prior antineoplastic therapy resulting in toxicity that has not recovered to <= CTCAE V5.0 Grade 1 prior to the first dose, excluding alopecia areata 3. have received pharmacologic or non-pharmacologic therapy for CIPN within 2 weeks prior to the first dose; 4. being on a combination or planning to start an antineoplastic therapy that may result in peripheral neurotoxicity within 6 months of the first dose of the drug 5. the presence of other causes of peripheral neuropathy; 6. the presence of skin disorders in the involved dermal area that, in the investigator's judgment, may interfere with the evaluation of neuropathic pain conditions at the time of screening; 7. the presence of non-CIPN pain at the time of screening that may interfere with study assessment and/or self-assessment of peripheral neuropathic pain; 8. the presence of a history of significant medical illness prior to the first dose, specifically: severe cardiovascular disease requiring hospitalization within 12 months prior to the first dose; gastrointestinal perforation, etc., within 6 months prior to the first dose; any serious arterial or venous thromboembolic event within 6 months prior to the first dose; and acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to the first dose; 9. major surgical procedure or serious trauma within 4 weeks prior to the first dose of the drug 10. a history of severe bleeding tendency or coagulopathy; 11. current uncontrolled co-morbidities; 12. the presence of a pleural effusion, pericardial effusion, or ascites that is clinically symptomatic or requires repeated drainage; 13. the presence of previous or current non-infectious pneumonia/interstitial lung disease requiring systemic glucocorticoid therapy 14. the current presence of active hepatitis B; active hepatitis C; participants with active syphilis infection; and those who have tested positive for antibodies to human immunodeficiency virus (HIV); 15. a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation 16. known hypersensitivity to any component of the study drug; 17. participants with chronic or active infections requiring systemic therapy (e.g., antibiotics or antiviral medications) within 2 weeks prior to the first dose; 18. pre-existing neurodegenerative diseases (e.g., Parkinson's disease, Alzheimer's disease, Huntington's disease) or neuromuscular disorders (e.g., multiple sclerosis, amyotrophic lateral sclerosis [ALS], polio, inherited neuromuscular diseases); 19. severe mental disorders (depression, psychosis), alcoholism or drug abuse; 20. pregnancy, breastfeeding, or non-acceptance of contraception; 21. other conditions judged by the investigator to be unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade >=2 peripheral neurotoxicity within 8 cycles of administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with chemotherapy-induced chronic peripheral neuropathy (CIPN);Difference between FACT/GOG-NTX-13 score score and baseline score at 8 cycles of administration;Change from baseline in pain at 8 cycles of administration;Change from baseline in sensitivity to cold exposure at day 1 of 2 cycles of dosing;Difference between FACT/GOG-NTX-13 scale score and baseline score on day 1 of each cycle;Incidence of >>= grade 2, 3, and 4 CIPN on day 1 of each cycle ;Difference between European Organization for Research and Treatment of Cancer Chemotherapy-induced Peripheral Neuropathy Quality of Life Questionnaire (EORTC QLQ-CIPN20) scores and baseline scores on day 1 of each cycle;Incidence of hand-foot syndrome (as assessed by the Hand-Foot Syndrome-Specific Quality of Life Scale [HFS-14]), alopecia, and gastrointestinal toxicity (as assessed by the NCI-CTCAE V5.0) during 8 cycles of drug administration;Percentage of participants terminated for neuropathy;Incidence of adverse events (TEAE) and treatment-related adverse events (TRAE) during the study period; | — |
Countries
China
Contacts
Public ContactCheng Peng
The First Affiliated Hospital of Nanyang Medical Specialized Higher School
Outcome results
None listed