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Efficacy and safety of combination of fluoroquinolone and trifluridine in patients with MMS advanced colorectal cancer after failure of second-line therapy

Efficacy and safety of combination of fluoroquinolone and trifluridine in patients with MMS advanced colorectal cancer after failure of second-line therapy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059983
Enrollment
Unknown
Registered
2022-05-14
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

colorectal cancer

Interventions

Treatment group:Fluoroquinolone combined with trifluridine tipiracil

Sponsors

Medical Oncology Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The subjects have certain reading ability, can communicate effectively with the researchers, and can sign the informed consent form in writing, and sign the informed consent form before enrollment; 2. When signing the informed consent, the age is 18-75 years old, both male and female; 3. Pathological diagnosis of intestinal adenocarcinoma; 4. Patients who have recurrence after surgery or have been transferred at the time of initial treatment and cannot undergo radical surgery; 5. According to RECIST1.1, at least one lesion in imaging examination is measurable; 6. Immunohistochemistry or gene sequencing is pMMR or MSS; 7. The patient has at least failed to receive second-line treatment, and the used schemes must include oxaliplatin, irinotecan and fluorouracil; If the adjuvant treatment progresses within half a year, the adjuvant treatment plan is first-line treatment. 1 The second-line treatment can include bevacizumab or cetuximab, and the progress within 3 months after the first-line or second-line treatment stops or changes to maintenance treatment can be defined as treatment failure; 8. ECOG PS 0-1 points; 9. The expected survival period is more than three months; 10. Functions of important organs meet further treatment; 11. Women of childbearing age must undergo serum pregnancy test within three days before the drug use, and the result is negative, and must be non-lactating. Women of childbearing age and men with partners of childbearing age must agree to use efficient contraception during the study period and within 6 months of the last medication; 12. The patient volunteered to participate in the clinical study and signed the informed consent form. The patient has good compliance and can cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Other malignant tumors occurred in the past five years, except for the following cases: fully treated thyroid cancer, non-melanoma skin cancer, effectively treated cervical carcinoma in situ, stage I ductal carcinoma in situ, stage I grade I endometrial carcinoma or other solid tumors, including lymphoma that has been effectively treated and has no evidence of disease for more than five years; 2. Eliminate moderate or above organ dysfunction; 3. Exclude patients who have previously been treated with trifluridine, tepidipine or VEGFR-TKi; 4. Excluding contraindications to receive trifluouridine, tepiridine or VEGFR-TKi; 5. Known brain metastasis or symptoms of brain metastasis; 6. No measurable lesions; 7. According to the judgment of the researcher, there are other factors that may affect the results of the study or lead to the forced termination of the study.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;Disease control rate;

Secondary

MeasureTime frame
overall survival;Objective response rate;

Countries

China

Contacts

Public ContactChunmei Shi

Fujian Medical University Union Hospital

scmfz@qq.com+86 13365910949

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026