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

• Status: Completed
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhen-Yu Ding

Criteria

Inclusion Criteria:

1. 65 years and older;

2. Histologically or cytologically confirmed unresectable metastatic colorectal cancer refractory to or unfit for standard therapies;

3. ECOG PS 0-1;

4. 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;

5. Life expectancy ≥ 3 months;

6. Cooperative in observation of adverse events and curative effect;

7. No other anti-tumor concomitant treatment (including steroid drugs);

8. Adequate organ and bone marrow functions;

9. At least one measurable lesion(s);

10. Signed the written informed consent and completed the geriatric questionnaire (G8 screening form) at the time of enrollment.

Exclusion Criteria:

1. Active upper gastrointestinal ulcer, obvious vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc which may affect drug absorption, distribution, metabolism, or clearance;

2. Evidence of central nervous system metastasis;

3. One of the following complications: uncontrolled hypertension, coronary artery disease, arrhythmia and heart failure;

4. Abuse of alcohol or drugs;

5. Less than 4 weeks from the last clinical trial;

6. Previous treatment with VEGFR inhibitors;

7. Severe uncontrolled disability with concurrent infection;

8. Proteinuria ≥ 2 + (1.0g / 24hr);

9. Uncontrollable gastrointestinal bleeding;

10. Arterial / venous thromboembolic events such as cerebrovascular accident (including transient ischemic attack) occurred within 12 months before the first dose;

11. Acute myocardial infarction, acute coronary syndrome or coronary artery bypass grafting occurred within 6 months before the first dose;

12. Fracture or wound that has not been cured for a long time;

13. Coagulation dysfunction, bleeding tendency or receiving anticoagulation treatment;

14. Congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (HBV DNA ≥ 103copies / ml after regular antiviral therapy);

15. Patients who are not suitable for the study judged by the researchers.