Colorectal CancerNCT07577505
Histidine Supplementation for Antitumor Immunity in Colorectal Cancer
A study testing Histidine in people with Colorectal Cancer, run by Jing-yuan Fang, MD, Ph. D at 1 site in China.
Trial summary
The goal of this clinical study is to learn whether oral histidine supplementation may be safely used to support antitumor immune function during standard colorectal cancer treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Histidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2026to Jun 2027
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years, regardless of sex.
- Body mass index (BMI) ≥18.5.
- NRS-2002 score <3.
- Diagnosed with stage II or higher colorectal cancer who require pharmacological intervention.
- Capable of oral intake of medication.
- Willing to participate in the study and provide written informed consent.
Who cannot join
- Participation in other interventional clinical trials (including drugs, nutritional supplements, medical devices, etc.) within 4 weeks prior to enrollment.
- Presence of ascites, severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralysis, mechanical intestinal obstruction, or active gastrointestinal bleeding.
- Allergy to sample components.
- Current use of other nutritional supplements that may affect the validity and effectiveness of the study results.
- Pregnant, lactating female patients or women with fertility who test positive in the baseline pregnancy test.
- Presence of cognitive impairments or mental illnesses that prevent understanding of the study procedures.
- Presence of any other conditions, judged by the researcher, make the participant unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Punan Hospital of Pudong New District
Shanghai, Shanghai Municipality
Fengyuan Chen, M.D., (86)18917107059, cfengyuan0211@163.com
About this study
Official title: A Single-arm Clinical Study of Histidine Supplementation for Antitumor Immunity in Colorectal Cancer
The goal of this clinical study is to learn whether oral histidine supplementation may be safely used to support antitumor immune function during standard colorectal cancer treatment.
Participants with colorectal cancer in the supplementation group will:
Take 2g oral histidine once daily during standard colorectal cancer treatment; Provide blood samples before and after supplementation; Attend regular follow-up visits for laboratory tests, safety assessment, and treatment evaluation.
- Conditions
- Colorectal Cancer
- Being tested
- Histidine
- Keywords
- Colorectal Cancer, Histidine, Immune functions
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistidineDietary supplement
Histidine capsules, 1000 mg per capsule, taken orally as 2 capsules once daily for 9 weeks. Histidine supplementation will be administered in addition to standard anti-tumor treatment determined by the treating physician according to clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Histidine supplement group | Experimental | Patients with colorectal cancer will receive oral histidine supplementation in addition to standard anti-tumor treatment for 9 weeks. Receives: Dietary Supplement: Histidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum histidine concentration
Serum histidine concentration measured using liquid chromatography-mass spectrometry (LC-MS).
Measured: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.
Percentage of IFN-gamma-positive T cells
Peripheral blood mononuclear cells (PBMCs) collected from patients with colorectal cancer will be assessed by flow cytometry to evaluate the percentage of IFN-gamma-positive T cells as a T cell effector function marker.
Measured: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.
Percentage of granzyme B-positive T cells
Peripheral blood mononuclear cells (PBMCs) collected from patients with colorectal cancer will be assessed by flow cytometry to evaluate the percentage of granzyme B-positive T cells as a T cell effector function marker.
Measured: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.
Secondary outcomes (1)
Tumor volume
Tumor volume will be assessed using available imaging examinations and/or colonoscopy findings, according to routine clinical evaluation in patients with colorectal cancer.
Measured: At the time of enrollment as baseline, and at the end of treatment at 9 weeks, and during follow-up at 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start6 May 2026
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing-yuan Fang, MD, Ph. D
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Punan Hospital of Pudong New District
- Responsible party
- Sponsor-investigator, Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jing-Yuan Fang, M.D., Study director, Division of Gastroenterology and Hepatology, NHC Key Laboratory of Digestive Diseases, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577505
- Sponsor's protocol ID
- (2025)YLD(024)
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Clinical Study of Histidine Supplementation for Antitumor Immunity in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07577505
- Acronym / sponsor ID
- (2025)YLD(024)
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Histidine, Immune functions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jing-yuan Fang, MD, Ph. DUniversity, hospital or other
- Collaborators
- Shanghai Punan Hospital of Pudong New District
- Study start
- 6 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 May 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.
The goal of this clinical study is to learn whether oral histidine supplementation may be safely used to support antitumor immune function during standard colorectal cancer treatment.
Participants with colorectal cancer in the supplementation group will:
Take 2g oral histidine once daily during standard colorectal cancer treatment; Provide blood samples before and after supplementation; Attend regular follow-up visits for laboratory tests, safety assessment, and treatment evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Histidine supplement group | Experimental | Dietary Supplement: HistidinePatients with colorectal cancer will receive oral histidine supplementation in addition to standard anti-tumor treatment for 9 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18-80 years, regardless of sex.
- Body mass index (BMI) ≥18.5.
- NRS-2002 score <3.
- Diagnosed with stage II or higher colorectal cancer who require pharmacological intervention.
- Capable of oral intake of medication.
Key exclusion criteria (7 listed)
- Participation in other interventional clinical trials (including drugs, nutritional supplements, medical devices, etc.) within 4 weeks prior to enrollment.
- Presence of ascites, severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralysis, mechanical intestinal obstruction, or active gastrointestinal bleeding.
- Allergy to sample components.
- Current use of other nutritional supplements that may affect the validity and effectiveness of the study results.
- Pregnant, lactating female patients or women with fertility who test positive in the baseline pregnancy test.
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 |
|---|---|---|
| HistidineHistidine capsules, 1000 mg per capsule, taken orally as 2 capsules once daily for 9 weeks. Histidine supplementation will be administered in addition to standard anti-tumor treatment determined by the treating physician according to clinical guidelines. | Dietary supplement | Histidine supplement group |
Primary outcome
Serum histidine concentration
Time frame: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.
Serum histidine concentration measured using liquid chromatography-mass spectrometry (LC-MS).
Percentage of IFN-gamma-positive T cells
Time frame: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.
Peripheral blood mononuclear cells (PBMCs) collected from patients with colorectal cancer will be assessed by flow cytometry to evaluate the percentage of IFN-gamma-positive T cells as a T cell effector function marker.
Percentage of granzyme B-positive T cells
Time frame: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.
Peripheral blood mononuclear cells (PBMCs) collected from patients with colorectal cancer will be assessed by flow cytometry to evaluate the percentage of granzyme B-positive T cells as a T cell effector function marker.
1 secondary outcome
Tumor volume
Time frame: At the time of enrollment as baseline, and at the end of treatment at 9 weeks, and during follow-up at 3 and 6 months.
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 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Jing-Yuan Fang, M.D. study director
Division of Gastroenterology and Hepatology, NHC Key Laboratory of Digestive Diseases, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histidine in people with Colorectal Cancer, run by Jing-yuan Fang, MD, Ph. D 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Aug 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Wan Du, M.D. ((86)13788972966, duwan2017@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum histidine concentration (time frame: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.). The study lists 3 primary outcomes in all. 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 20 Aug 2026.