Colorectal AdenomaPhase 2NCT06722950
Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy
A Phase 2 study testing CAPEOX and AC591 in people with Colorectal Adenoma, run by Shandong New Time Pharmaceutical Co., LTD.
Trial summary
A randomized, double-blind, placebo-controlled, multicenter, Phase II clinical study of AC591 in preventing Oxaliplatin-Induced Peripheral Neuropathy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Adenoma
- What is being tested?
- CAPEOX and AC591
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand the experimental procedures and contents, and voluntarily sign a written informed consent;
- Male or female subjects aged 18 to 75 years (inclusive) when signing the informed consent;
- 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;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before the first medication in the study;
- Organ function level before the first medication in the study meets the following requirements:
- 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.
- Male or female subjects of fertility are required to take effective medical contraceptive measures until 3 months after the last study administration.
Who cannot join
- 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);
- Patients diagnosed with damp-heat syndrome or liver depression-fire syndrome according to TCM during the screening period;
- Patients with severe diabetic peripheral neuropathy (such as muscle atrophy as the main stage) and abnormal electromyography;
- Patients with known allergic reactions to any component of the study drug;
- Patients with intestinal obstruction that requires treatment;
- Active severe clinical infection (> grade 2, National Cancer Institute-Common Adverse Event Evaluation Criteria [NCI-CTCAE V5.0]), including active tuberculosis;
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- 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;
- 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);
- Patients who need to take coumarin derivative anticoagulants (such as warfarin, phenprocoumon) regularly within 3 weeks before screening or during the study;
- 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;
- Renal replacement therapy;
- Previous history of organ transplantation, autologous/allogeneic stem cell transplantation;
- 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;
- 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;
- Pregnancy (confirmed by menstrual pregnancy test) or lactation;
- Current alcohol or drug dependence;
- Suffering from known mental illness disorders that may affect trial compliance;
- Adverse events of previous anti-tumor treatment have not recovered to grade 1 (NCI-CTCAE V5.0) or abnormalities have no clinical significance;
- Subjects who have participated in other interventional clinical trials within 4 weeks before the first study drug;
- The investigator believes that the patient has other factors that affect the efficacy or safety evaluation of this study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy
A randomized, double-blind, placebo-controlled, multicenter, Phase II clinical study of AC591 in preventing Oxaliplatin-Induced Peripheral Neuropathy
Read the detailed description
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).
- Conditions
- Colorectal Adenoma
- Being tested
- CAPEOX, Placebo, AC591
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPEOXDrug
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.
PlaceboDrug
Placebo：3 times a day (daily), taken with boiled water.
AC591Drug
AC591 : 3 times a day (daily), taken with boiled water.
| Study group | Role | What they receive |
|---|---|---|
| AC591+CAPEOX | Experimental | AC591 granules (3 times a day) + CAPEOX chemotherapy Receives: Drug: CAPEOX; Drug: AC591 |
| Placebo+CAPEOX | Placebo comparator | Placebo (3 times a day) + CAPEOX chemotherapy Receives: Drug: CAPEOX; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool
Measured: At the end of Cycle 4 （each cycle is 21 days）
Secondary outcomes (10)
Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool
Measured: At the end of Cycle 8（each cycle is 21 days）
The time of onset of grade 1-3 oxaliplatin-induced peripheral neuropathy assessed by the Levi rating tool for oxaliplatin
Measured: At the end of Cycle 4 and 8（each cycle is 21 days）
The incidence of NCI-CTCAE V5.0 ≥ grade 2 neurotoxicity in subjects during CAPEOX chemotherapy
Measured: At the end of Cycle 4 and 8（each cycle is 21 days）
The change in the EORTC-QLQ-CIPN20 score of subjects during CAPEOX chemotherapy from baseline
Measured: at the end of each cycle（each cycle is 21 days）
The change in the EORTCQLQ-C30 score of subjects during CAPEOX chemotherapy from baseline
Measured: At the end of Cycle 4 and 8（each cycle is 21 days）
The proportion of subjects who used analgesics due to peripheral neuropathy caused by CAPEOX chemotherapy
Measured: At the end of Cycle 4 and 8（each cycle is 21 days）
The proportion of subjects who developed acute peripheral neuropathy within 3 days after the first CAPEOX chemotherapy
Measured: At the end of Cycle 4 and 8（each cycle is 21 days）
The average cumulative dose of oxaliplatin received by the subjects during CAPEOX chemotherapy
Measured: At the end of Cycle 4 and 8（each cycle is 21 days）
The incidence of gastrointestinal adverse reactions in the subjects during CAPEOX chemotherapy
Measured: At the end of Cycle 4 and 8（each cycle is 21 days）
The proportion of subjects who did not experience neurotoxicity as assessed by the Levi rating tool dedicated to oxaliplatin
Measured: At the end of Cycle 4 and 8（each cycle is 21 days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722950
- Sponsor's protocol ID
- NTP-AC591-001
- Other IDs
- Shandong New Time Pharmaceutic
- Status last verified
- Dec 2024
- First submitted
- 22 Oct 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06722950
- Acronym / sponsor ID
- NTP-AC591-001
- Conditions
- Colorectal Adenoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, placebo-controlled, multicenter, Phase II clinical study of AC591 in preventing Oxaliplatin-Induced Peripheral Neuropathy
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC591+CAPEOX | Experimental | Drug: CAPEOX, Drug: AC591AC591 granules (3 times a day) + CAPEOX chemotherapy |
| Placebo+CAPEOX | Placebo comparator | Drug: CAPEOX, Drug: PlaceboPlacebo (3 times a day) + CAPEOX chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Understand the experimental procedures and contents, and voluntarily sign a written informed consent;
- Male or female subjects aged 18 to 75 years (inclusive) when signing the informed consent;
- 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;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before the first medication in the study;
- Organ function level before the first medication in the study meets the following requirements:
Key exclusion criteria (20 listed)
- 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);
- Patients diagnosed with damp-heat syndrome or liver depression-fire syndrome according to TCM during the screening period;
- Patients with severe diabetic peripheral neuropathy (such as muscle atrophy as the main stage) and abnormal electromyography;
- Patients with known allergic reactions to any component of the study drug;
- Patients with intestinal obstruction that requires treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAPEOXCAPEOX: 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. | Drug | AC591+CAPEOX, Placebo+CAPEOX |
| PlaceboPlacebo：3 times a day (daily), taken with boiled water. | Drug | Placebo+CAPEOX |
| AC591AC591 : 3 times a day (daily), taken with boiled water. | Drug | AC591+CAPEOX |
Primary outcome
Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool
Time frame: At the end of Cycle 4 （each cycle is 21 days）
10 secondary outcomes
Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool
Time frame: At the end of Cycle 8（each cycle is 21 days）
The time of onset of grade 1-3 oxaliplatin-induced peripheral neuropathy assessed by the Levi rating tool for oxaliplatin
Time frame: At the end of Cycle 4 and 8（each cycle is 21 days）
The incidence of NCI-CTCAE V5.0 ≥ grade 2 neurotoxicity in subjects during CAPEOX chemotherapy
Time frame: At the end of Cycle 4 and 8（each cycle is 21 days）
The change in the EORTC-QLQ-CIPN20 score of subjects during CAPEOX chemotherapy from baseline
Time frame: at the end of each cycle（each cycle is 21 days）
The change in the EORTCQLQ-C30 score of subjects during CAPEOX chemotherapy from baseline
Time frame: At the end of Cycle 4 and 8（each cycle is 21 days）
The proportion of subjects who used analgesics due to peripheral neuropathy caused by CAPEOX chemotherapy
Time frame: At the end of Cycle 4 and 8（each cycle is 21 days）
The proportion of subjects who developed acute peripheral neuropathy within 3 days after the first CAPEOX chemotherapy
Time frame: At the end of Cycle 4 and 8（each cycle is 21 days）
The average cumulative dose of oxaliplatin received by the subjects during CAPEOX chemotherapy
Time frame: At the end of Cycle 4 and 8（each cycle is 21 days）
The incidence of gastrointestinal adverse reactions in the subjects during CAPEOX chemotherapy
Time frame: At the end of Cycle 4 and 8（each cycle is 21 days）
The proportion of subjects who did not experience neurotoxicity as assessed by the Levi rating tool dedicated to oxaliplatin
Time frame: At the end of Cycle 4 and 8（each cycle is 21 days）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAPEOX and AC591 in people with Colorectal Adenoma, run by Shandong New Time Pharmaceutical Co., LTD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhang jian xiang (0539-8330397, jianxiangzhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool (time frame: At the end of Cycle 4 （each cycle is 21 days）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.