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A Single-arm Clinical Study of Histidine Supplementation for Antitumor Immunity in Colorectal Cancer

Mechanistic study of histidine-mediated regulation of antigen presentation in colorectal cancer to enhance sensitivity to immunotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124057
Enrollment
Unknown
Registered
2026-05-06
Start date
2026-05-08
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Colorectal cancer (CRC) group:None
Intervention group:Histidine capsules administered orally
Healthy control group:None

Sponsors

Punan Hospital,Pudong New District, Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–80 years, regardless of sex; 2. Body mass index (BMI) >=18.5; 3. NRS-2002 score <3; 4. Patients diagnosed with stage II or higher colorectal cancer who require pharmacological intervention; 5. Able to take oral medication; 6. Willing to participate in the study and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Participation in another interventional clinical trial (including drugs, nutritional supplements, or medical devices) within 4 weeks prior to enrollment; 2. Presence of ascites, severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralysis, mechanical intestinal obstruction, or active gastrointestinal bleeding; 3. Known allergy to any component of the study product; 4. Current use of other nutritional supplements that may affect the validity of the study results; 5. Positive pregnancy test at baseline, breastfeeding women, or women of childbearing potential who are pregnant; 6. Presence of cognitive impairment or psychiatric disorders that prevent understanding of the study procedures; 7. Any other condition that, in the investigator’s judgment, makes the participant unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Peripheral blood immune cell function;Serum histidine level;

Secondary

MeasureTime frame
Tumor volume;

Countries

China

Contacts

Public ContactChen Fengyuan

Punan Hospital,Pudong New District, Shanghai

Cfy429@163.com+86 18917107059

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026