Clinical trial NCT04866108: A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy
Official title: A Single Center, Open-labeled, Single Arm Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Unresectable Metastatic Colorectal Cancer
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single center, open-labeled, single arm phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients unsuitable for intravenous chemotherapy.

Detailed description: Fruquintinib is an oral small molecule inhibitor of VEGFR1/2/3, this phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients of elderly or those unsuitable for intravenous chemotherapy.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years old at the time of signing the informed consent;
2. Histologically or cytologically confirmed unresectable metastatic colorectal cancer;
3. Haven't received systematic therapy after diagnosis of metastatic colorectal cancer;
4. Intolerable to standard treatment of oxaliplatin- or irinotecan-based intravenous combination therapy;
5. At least one measurable lesion(s);
6. ECOG PS 0-2;
7. Life expectancy≥3 months;
8. Adequate organ and bone marrow functions;
9. Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration;
10. Willingness and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

1. Previous treatment with VEGFR inhibition;
2. Participating in other drug clinical trials within 4 weeks before recruited;
3. Have received other systemic anti-tumor therapies within 4 weeks before recruited;
4. Non-controlled hypertension after monotherapy, that is, systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg;
5. Proteinuria ≥ 2+ (1.0g/24hr);
6. Clinically significant electrolyte abnormality;
7. Clinically significant cardiovascular diseases;
8. Thromboembolism or arteriovenous events occurred 6 months before recruited;
9. ≥grade 3 bleeding events 4 weeks before recruited;
10. Evidence of CNS metastasis;
11. Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI;
12. Active, symptomatic interstitial lung disease causing dyspnea (≥ grade 2 dyspnea), pleural effusion or ascites;
13. History of organ transplantation;
14. APTT \>1.5×ULN or INR\>1.5;
15. History of HIV infection or active hepatitis B / C;
16. Allergic to fruquintinib and / or capecitabine;
17. Pregnant or lactating women;
18. Clinically detectable secondary primary malignancies at the time of enrollment (excluding fully treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
19. Patients who are not suitable for the study judged by the researchers.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From Baseline to primary completion date, about 3 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From Baseline to primary completion date, about 3 years
measure: Progression Free Survival (PFS)
timeFrame: From Baseline to primary completion date, about 3 years
measure: Disease Control Rate (DCR)
timeFrame: From Baseline to primary completion date, about 3 years
measure: Adverse Events and Serious Adverse Events
timeFrame: From Baseline to primary completion date, about 3 years
measure: Quality of Life (QoL)
timeFrame: From Baseline to primary completion date, about 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
Study officials:
References: