Colorectal CancerPhase 3NCT07320950
Neuroprotective Effect of Neurotropin on Chronic OXA-induced Neurotoxicity in Stage II and Stage III CRC Patients
A Phase 3 study testing Neurotropin in people with Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Oxaliplatin is effective in adjuvant and first-line colorectal cancer chemotherapy. Oxaliplatin-induced severe chronic neurotoxicity is the main dose-limiting adverse event. No standard treatment for oxaliplatin-induced chronic toxicity has been defined. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Neurotropin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 22 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 18 to 75 years old
- Stage II or III colorectal cancer patients confirmed by pathological diagnosis, and recovered from surgery within 8 weeks
- should receive adjuvant chemotherapy especially XELOX regimen after assessment by physicians and specialists
- Agreed and assigned the consent, and was able to receive the baseline assessment
- Could be inpatient or outpatient participants
Who cannot join
- Peripheral neuropathy patients, e.g. diabetes neuropathy
- Alcoholic related patients
- Central neuropathy patients
- Patients who were unable to assess the effectivity and safety
- Neurotropin allergy
- History of medications that are contraindicated to neurotropin <28 days before the trial begins
Show all 17Show fewer
- Have already received neurotropin tablets more than 4 tablets or 3.6 units <4 weeks before the trials begins
- Unable to visit the hospital regularly
- Has been ruled out by investigators
- Brain tumor or metastasis
- Brain injury, stroke and brain hemorrhage symptoms occurred during 6 months after sign the consent
- History of epilepsy, convulsion
- Severe respiratory, cardiovascular, renal, hepatic or hematologic system(except cancer) disease
- Depression and other psychologic conditions which investigators recognized as high risk for the enrollment
- Chronic pain
- Received other medication from other clinical trials within 28 days
- Prepare for pregnancy, pregnant, or lactated women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuroprotective Effect of Neurotropin on Chronic Oxaliplatin-induced Neurotoxicity in Stage II and Stage III Colorectal Cancer Patients: a Randomized, Double-blind, Placebo-controlled, Parallel Grouping Multi-center Clinical Trial
Oxaliplatin is effective in adjuvant and first-line colorectal cancer chemotherapy. Oxaliplatin-induced severe chronic neurotoxicity is the main dose-limiting adverse event. No standard treatment for oxaliplatin-induced chronic toxicity has been defined. Neurotropin has been identified as a strategy for reducing the peripheral neurotoxicity in the published studies. Our aim is to define the best intake dose and evaluate the safety of neurotropin for peripheral neurotoxicity of oxaliplatin by conducting a placebo-controlled clinical trial.
- Conditions
- Colorectal Cancer
- Being tested
- Neurotropin, Placebo
- Keywords
- Adverse event, Oxaliplatin, Neurotoxicity, Neurotropin, Management
- Medical subject headings
- Colorectal Neoplasms, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurotropinDrug
Participants would be assess the safety and evaluate the neurotoxicity after the last cycle of whole chemotherapy regimen.
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Neurotropin 4 tablets/day | Experimental | All the patients in this group received neurotropin 4 tablets a day ( 2 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles. Receives: Drug: Neurotropin |
| Neurotropin 8 tablets/day | Experimental | All the patients in this group received neurotropin 8 tablets a day ( 4 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles. Receives: Drug: Neurotropin |
| Placebo | Placebo comparator | All the patients in this group received placebo 8 tablets a day ( 4 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of peripheral neurotoxicity among groups
Oxaliplatin specific neurotoxicity grade classification and assessment. Incidence of Grade 3 or higher peripheral neuropathy at the end of adjuvant chemotherapy
Measured: At the end of chemotherapy (up to 8 cycles, each cycle is 21 days)
Secondary outcomes (5)
The completion rate of oxaliplatin based chemotherapy
Calculate the exact cycles that the participants completed
Measured: At the end of chemotherapy (up to 8 cycles, each cycle is 21 days)
Fine motor functions assessment
Questionaire to assess whether the patient could complete the fine movement such as writing and zip up
Measured: From completion of adjuvant chemotherapy, assessed at 2 years.
Time from total recovery from neurotoxicity after the chemotherapy
The time (in months) from the first documented complete resolution of chemotherapy-induced peripheral neuropathy. Participants without recurrence will be censored at the date of last follow-up within the 3-year study period.
Measured: From completion of chemotherapy, up to 3 years.
Disease-Free Survival (DFS) Rate at 3 Years
The proportion of participants who are alive and free of disease (i.e., have not experienced disease recurrence or a new primary cancer) at 3 years from the date of randomization (or start of treatment).
Measured: From randomization up to 3 years
Overall Survival (OS) Rate at 3 Years
OS is defined as the time from the date of randomization to the date of death from any cause. Participants who are still alive at the time of analysis will be censored at the last known alive date.
Measured: From randomization up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Apr 2022
- Primary completion30 Aug 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gong Chen, Sun Yat-Sen University Cancer Center
- Investigators
- Gong Chen, Prof, Principal investigator, Sun Yat-sen UniversityZhi-zhong Pan, Prof, Study chair, Sun Yat-sen UniversityDe-Sen Wan, Prof, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320950
- Sponsor's protocol ID
- B2020-061-01
- Status last verified
- Dec 2025
- First submitted
- 4 Jan 2022
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotective Effect of Neurotropin on Chronic Oxaliplatin-induced Neurotoxicity in Stage II and Stage III Colorectal Cancer Patients: a Randomized, Double-blind, Placebo-controlled, Parallel Grouping Multi-center Clinical Trial
- ClinicalTrials.gov ID
- NCT07320950
- Acronym / sponsor ID
- B2020-061-01
- Conditions
- Colorectal Cancer
- Keywords
- Adverse event, Oxaliplatin, Neurotoxicity, Neurotropin, Management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 6 Jan 2026 (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.
Oxaliplatin is effective in adjuvant and first-line colorectal cancer chemotherapy. Oxaliplatin-induced severe chronic neurotoxicity is the main dose-limiting adverse event. No standard treatment for oxaliplatin-induced chronic toxicity has been defined. Neurotropin has been identified as a strategy for reducing the peripheral neurotoxicity in the published studies. Our aim is to define the best intake dose and evaluate the safety of neurotropin for peripheral neurotoxicity of oxaliplatin by conducting a placebo-controlled clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neurotropin 4 tablets/day | Experimental | Drug: NeurotropinAll the patients in this group received neurotropin 4 tablets a day ( 2 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles. |
| Neurotropin 8 tablets/day | Experimental | Drug: NeurotropinAll the patients in this group received neurotropin 8 tablets a day ( 4 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles. |
| Placebo | Placebo comparator | Other: PlaceboAll the patients in this group received placebo 8 tablets a day ( 4 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 75 years old
- Stage II or III colorectal cancer patients confirmed by pathological diagnosis, and recovered from surgery within 8 weeks
- should receive adjuvant chemotherapy especially XELOX regimen after assessment by physicians and specialists
- Agreed and assigned the consent, and was able to receive the baseline assessment
- Could be inpatient or outpatient participants
Key exclusion criteria (17 listed)
- Peripheral neuropathy patients, e.g. diabetes neuropathy
- Alcoholic related patients
- Central neuropathy patients
- Patients who were unable to assess the effectivity and safety
- Neurotropin allergy
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 |
|---|---|---|
| NeurotropinParticipants would be assess the safety and evaluate the neurotoxicity after the last cycle of whole chemotherapy regimen. | Drug | Neurotropin 4 tablets/day, Neurotropin 8 tablets/day |
| Placeboplacebo | Other | Placebo |
Primary outcome
The incidence of peripheral neurotoxicity among groups
Time frame: At the end of chemotherapy (up to 8 cycles, each cycle is 21 days)
Oxaliplatin specific neurotoxicity grade classification and assessment. Incidence of Grade 3 or higher peripheral neuropathy at the end of adjuvant chemotherapy
5 secondary outcomes
The completion rate of oxaliplatin based chemotherapy
Time frame: At the end of chemotherapy (up to 8 cycles, each cycle is 21 days)
Fine motor functions assessment
Time frame: From completion of adjuvant chemotherapy, assessed at 2 years.
Time from total recovery from neurotoxicity after the chemotherapy
Time frame: From completion of chemotherapy, up to 3 years.
Disease-Free Survival (DFS) Rate at 3 Years
Time frame: From randomization up to 3 years
Overall Survival (OS) Rate at 3 Years
Time frame: From randomization up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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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. This study is not recruiting at the moment.
Gong Chen, Prof principal investigator
Sun Yat-sen University
Zhi-zhong Pan, Prof study chair
Sun Yat-sen University
De-Sen Wan, Prof study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neurotropin in people with Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
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 5 inclusion and 17 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: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of peripheral neurotoxicity among groups (time frame: At the end of chemotherapy (up to 8 cycles, 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 6 Jan 2026.