Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
Study NCT ID:
NCT06722950
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-10-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool', 'timeFrame': 'At the end of Cycle 4 （each cycle is 21 days）'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool', 'timeFrame': 'At the end of Cycle 8（each cycle is 21 days）'}, {'measure': 'The time of onset of grade 1-3 oxaliplatin-induced peripheral neuropathy assessed by the Levi rating tool for oxaliplatin', 'timeFrame': 'At the end of Cycle 4 and 8（each cycle is 21 days）'}, {'measure': 'The incidence of NCI-CTCAE V5.0 ≥ grade 2 neurotoxicity in subjects during CAPEOX chemotherapy', 'timeFrame': 'At the end of Cycle 4 and 8（each cycle is 21 days）'}, {'measure': 'The change in the EORTC-QLQ-CIPN20 score of subjects during CAPEOX chemotherapy from baseline', 'timeFrame': 'at the end of each cycle（each cycle is 21 days）'}, {'measure': 'The change in the EORTCQLQ-C30 score of subjects during CAPEOX chemotherapy from baseline', 'timeFrame': 'At the end of Cycle 4 and 8（each cycle is 21 days）'}, {'measure': 'The proportion of subjects who used analgesics due to peripheral neuropathy caused by CAPEOX chemotherapy', 'timeFrame': 'At the end of Cycle 4 and 8（each cycle is 21 days）'}, {'measure': 'The proportion of subjects who developed acute peripheral neuropathy within 3 days after the first CAPEOX chemotherapy', 'timeFrame': 'At the end of Cycle 4 and 8（each cycle is 21 days）'}, {'measure': 'The average cumulative dose of oxaliplatin received by the subjects during CAPEOX chemotherapy', 'timeFrame': 'At the end of Cycle 4 and 8（each cycle is 21 days）'}, {'measure': 'The incidence of gastrointestinal adverse reactions in the subjects during CAPEOX chemotherapy', 'timeFrame': 'At the end of Cycle 4 and 8（each cycle is 21 days）'}, {'measure': 'The proportion of subjects who did not experience neurotoxicity as assessed by the Levi rating tool dedicated to oxaliplatin', 'timeFrame': 'At the end of Cycle 4 and 8（each cycle is 21 days）'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Adenoma']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, placebo-controlled, multicenter, Phase II clinical study of AC591 in preventing Oxaliplatin-Induced Peripheral Neuropathy', 'detailedDescription': 'This multicenter, randomized, double-blind, placebo-controlled trial aims to explore the effectiveness of AC591 particles in preventing oxaliplatin-induced peripheral neuropathy. Patients with colorectal adenocarcinoma who are prepared to receive CAPEOX (capecitabine tablets + oxaliplatin injection) postoperative adjuvant chemotherapy within 3 weeks to 2 months after surgery will be randomized in a 1:1 ratio. The subjects will be stratified based on the chemotherapy cycles they are prepared to receive CAPEOX (4 cycles vs 8 cycles).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Understand the experimental procedures and contents, and voluntarily sign a written informed consent;\n2. Male or female subjects aged 18 to 75 years (inclusive) when signing the informed consent;\n3. Patients with histologically confirmed colorectal adenocarcinoma. Prepare to receive CAPEOX postoperative adjuvant chemotherapy within 3 weeks to 2 months after surgery, and have never used oxaliplatin;\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before the first medication in the study;\n5. Organ function level before the first medication in the study meets the following requirements:\n\n Peripheral blood cell count: white blood cell count ≥3×109/L and neutrophil ≥1.5×109/L, platelet count ≥75×109/L, hemoglobin ≥90g/L; Liver function: total bilirubin ≤1.5 times the upper limit of normal reference value; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal reference value; Renal function: serum creatinine ≤1.5 times the upper limit of normal reference value.\n6. Male or female subjects of fertility are required to take effective medical contraceptive measures until 3 months after the last study administration.\n\nExclusion Criteria:\n\n1. known neurodegenerative disease (e.g., Parkinson's disease, Alzheimer's disease, Huntington's disease) or neuromuscular disease (e.g., multiple sclerosis, amyotrophic lateral sclerosis, poliomyelitis, hereditary neuromuscular disease);\n2. Patients diagnosed with damp-heat syndrome or liver depression-fire syndrome according to TCM during the screening period;\n3. Patients with severe diabetic peripheral neuropathy (such as muscle atrophy as the main stage) and abnormal electromyography;\n4. Patients with known allergic reactions to any component of the study drug;\n5. Patients with intestinal obstruction that requires treatment;\n6. Active severe clinical infection (\\> grade 2, National Cancer Institute-Common Adverse Event Evaluation Criteria \\[NCI-CTCAE V5.0\\]), including active tuberculosis;\n7. Uncontrolled diabetes, severe lung disease (such as acute lung disease, pulmonary fibrosis affecting lung function, interstitial lung disease, but excluding recovered radiation pneumonia), liver failure;\n8. Clinically significant cardiovascular disease, New York Heart Association \\[NYHA\\] grade III-IV congestive heart failure, unstable angina, myocardial infarction, etc. within 6 months before the first dose. Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg after adequate treatment);\n9. Patients who need to take coumarin derivative anticoagulants (such as warfarin, phenprocoumon) regularly within 3 weeks before screening or during the study;\n10. Patients who have used drugs that interfere with the evaluation of neuropathic pain (such as antidepressants, antiepileptic drugs) within 2 weeks before the first dose;\n11. Renal replacement therapy;\n12. Previous history of organ transplantation, autologous/allogeneic stem cell transplantation;\n13. History of other malignant tumors except colorectal cancer in the past 5 years. However, cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or early papillary thyroid carcinoma are excluded;\n14. HIV infection, hepatitis B surface antigen positive (and peripheral blood hepatitis B virus deoxynucleotide HBV DNA ≥ 1×104 copies/mL or ≥ 2000IU/mL), hepatitis C virus antibody positive (and peripheral blood hepatitis C virus nucleotide HCV RNA ≥ 1×103 copies/ml or ≥ 200IU/mL) or active syphilis patients;\n15. Pregnancy (confirmed by menstrual pregnancy test) or lactation;\n16. Current alcohol or drug dependence;\n17. Suffering from known mental illness disorders that may affect trial compliance;\n18. Adverse events of previous anti-tumor treatment have not recovered to grade 1 (NCI-CTCAE V5.0) or abnormalities have no clinical significance;\n19. Subjects who have participated in other interventional clinical trials within 4 weeks before the first study drug;\n20. The investigator believes that the patient has other factors that affect the efficacy or safety evaluation of this study"}, 'identificationModule': {'nctId': 'NCT06722950', 'briefTitle': 'Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong New Time Pharmaceutical Co., LTD'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'NTP-AC591-001'}, 'secondaryIdInfos': [{'id': 'Shandong New Time Pharmaceutic', 'type': 'OTHER', 'domain': 'Shandong New Time Pharmaceutical Co., Ltd.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AC591+CAPEOX', 'description': 'AC591 granules (3 times a day) + CAPEOX chemotherapy', 'interventionNames': ['Drug: CAPEOX', 'Drug: AC591']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo+CAPEOX', 'description': 'Placebo (3 times a day) + CAPEOX chemotherapy', 'interventionNames': ['Drug: CAPEOX', 'Drug: Placebo']}], 'interventions': [{'name': 'CAPEOX', 'type': 'DRUG', 'description': 'CAPEOX: 130mg/m2 of oxaliplatin (D1, central intravenous drip for 2h (time window + 20min)), 1000mg/m2 of capecitabine tablets each time, orally, twice a day (D1-D14, morning and evening); repeat the CAPEOX chemotherapy regimen every 3 weeks.', 'armGroupLabels': ['AC591+CAPEOX', 'Placebo+CAPEOX']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo：3 times a day (daily), taken with boiled water.', 'armGroupLabels': ['Placebo+CAPEOX']}, {'name': 'AC591', 'type': 'DRUG', 'description': 'AC591 : 3 times a day (daily), taken with boiled water.', 'armGroupLabels': ['AC591+CAPEOX']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhang jian xiang', 'role': 'CONTACT', 'email': 'jianxiangzhang@126.com', 'phone': '0539-8330397'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong New Time Pharmaceutical Co., LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}