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Assessment of the Dose Safety and Efficacy of Serine Combined With Fluorouracil Drugs | Clinical Trials | Clareo Health

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Assessment of the Dose Safety and Efficacy of Serine Combined With Fluorouracil Drugs

NCT07178613•The First Affiliated Hospital of Xinxiang Medical College

Summary

This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration. Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years (inclusive), male or female;
•2. Patients with advanced colorectal cancer confirmed by histopathological or cytological examination, eligible for standard first-line treatment with fluorouracil-containing regimens.
•3. Patients must have at least one measurable lesion.
•4. ECOG performance status ≤ 2.
•5. Expected survival ≥ 3 months;
•6. Major organ functions are essentially normal, with laboratory tests meeting the following criteria:
•Hematology (no transfusion of blood or blood products within 7 days prior to testing; no use of G-CSF or other hematopoietic growth factors for correction):
•Absolute neutrophil count ≥1.5×10⁹/L ; Platelets ≥75×10⁹/L ; Hemoglobin ≥90 g/L;
•Renal:
•Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) \>60 mL/min/1.73 m² (Cockcroft-Gault formula);
+8 more criteria

Exclusion Criteria

•1. Trial Participation Restrictions: Currently participating in or having received investigational drug/device treatment within the past 4 weeks;
•2. Prior Fluorouracil-Based Therapy Restrictions: History of ≥Grade 3 toxicity (e.g., myelosuppression, gastrointestinal toxicity) following prior fluorouracil-based therapy, deemed unsuitable for re-administration by the investigator;
•3. Recent Surgery Restriction: Undergone major surgery (excluding diagnostic biopsy) within 28 days prior to first dosing, or scheduled for surgery during the study period;
•4. Metabolic and Nutritional Status Restriction: Presence of severe malnutrition (BMI \< 18.5 or serum albumin \< 30 g/L), or inability to supplement serine orally (e.g., malabsorption syndrome, short bowel syndrome); Known serine metabolism disorders (e.g., PHGDH/PSAT1 gene mutation-related diseases);
•5. Concurrent severe disease restrictions: Severe cardiovascular disease (NYHA Class III/IV heart failure, myocardial infarction within 6 months, uncontrolled hypertension \>150/100 mmHg); severe respiratory disease (COPD, GOLD Stage ≥3, interstitial lung disease); Active infection (requiring systemic antibiotic/antiviral therapy);
•6. Active HIV/viral hepatitis: HIV-positive status, or active hepatitis B (HBV-DNA ≥ 2000 IU/mL), or active hepatitis C (HCV-RNA positive); (Note: Patients with HBV-DNA \< 2000 IU/mL receiving antiviral therapy may be enrolled);
•7. Neurological disorders: Uncontrolled brain metastases (with intracranial hypertension or neurological symptoms), or history of severe psychiatric illness/substance abuse (impeding treatment compliance);
•8. Allergy history: Known allergy to fluorouracil-based drugs or serine supplements;
•9. Pregnancy/lactation: Pregnant or lactating women (patients of childbearing potential must use highly effective contraception);
•10. Other conditions deemed ineligible by the investigator: Any concomitant conditions or laboratory abnormalities that may interfere with study results, increase risk, or compromise patient safety.

Key Dates

Start Date

November 1, 2025

Primary Completion Date

February 1, 2026

Completion Date

February 1, 2026

Last Updated

September 17, 2025

Enrollment

ESTIMATED participants

Conditions

Advanced Colorectal Cancer

Interventions

Serine（Oral）

DRUG

Fluoropyrimidine Drugs

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessment of the Dose Safety and Efficacy of Serine Combined With Fluorouracil Drugs

Inclusion Criteria

Exclusion Criteria

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