CompletedPhase 2

A Phase II Study on Dose Optimization of Fruquintinib in Elderly mCRC Patients Refractory to Standard Treatment（DOFEMCRC）

China29 participantsStarted 2020-11-06

Plain-language summary

A Phase II study on dose optimization of fruquintinib in elderly metastatic colorectal cancer patients refractory to standard treatment.

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 65 years and older;
✓. Histologically or cytologically confirmed unresectable metastatic colorectal cancer refractory to or unfit for standard therapies;
✓. ECOG PS 0-1;
✓. At least 4 weeks after the last anti-tumor therapy (chemotherapy, radiotherapy, biotherapy or hormone therapy) and more than 3 months after operation treatment before enrollment;
✓. Life expectancy ≥ 3 months;
✓. Cooperative in observation of adverse events and curative effect;
✓. No other anti-tumor concomitant treatment (including steroid drugs);
✓. Adequate organ and bone marrow functions;

✕. Active upper gastrointestinal ulcer, obvious vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc which may affect drug absorption, distribution, metabolism, or clearance;
✕. Evidence of central nervous system metastasis;
✕. One of the following complications: uncontrolled hypertension, coronary artery disease, arrhythmia and heart failure;
✕. Abuse of alcohol or drugs;
✕. Less than 4 weeks from the last clinical trial;
✕. Previous treatment with VEGFR inhibitors;
✕. Severe uncontrolled disability with concurrent infection;
✕. Proteinuria ≥ 2 + (1.0g / 24hr);

PFS

Timeframe: about a year

NCT IDNCT05025631

SponsorZhen-Yu Ding

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-30