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Capecitabine

Antimetabolites

Ⅰb: capecitabine: 1000 mg/m²，PO BID, d1-14，Q3W; fruquintinib 3mg/4mg/5mg, d1-14, PO QD, Q3W.

ⅠⅠ: fruquintinib RP2D, d1-14, PO QD, Q3W, capecitabine: 1000 mg/m²，PO BID, d1-14，Q3W

fruquintinib plus capecitabine

Lin Yang, M.D.

Lin Yang, M.D

This phase I/II study was designed to evaluate the efficacy and safety of fruquintinib combination with capecitabine in maintenance treatment after first-line chemotherapy combined with cetuximab.

At present, most studies use chemotherapy combined with cetuximab or cetuximab alone as the maintenance treatment scheme after the first-line regimen containing cetuximab. However, the skin reaction caused by cetuximab and frequent infusion treatment will bring inconvenience to patients. MACBETH study compared the maintenance of bevacizumab with cetuximab, although there was no significant difference in PFS between them, the Bev group seemed to convey a longer median OS. Fruquintinib is a highly selective anti angiogenesis TKI. This study aims to explore the efficacy and safety of fruquintinib combined with capecitabine in maintenance treatment after first-line chemotherapy combined with cetuximab. Both fruquintinib and capecitabine are orally given, so this regimen may provide a maintenance treatment option that is more manageable for patients in clinical practice.

Fruquintinib Plus Capecitabine as Maintenance Treatment of RAS / BRAF Wild-type Metastatic Colorectal Cancer

A Phase Ⅰb/Ⅱ Study of Fruquintinib Combined With Capecitabine in the First-line Maintenance Treatment of RAS/BRAF Wild-type Metastatic Colorectal Cancer

RP2D is determined according to DLT and MTD in the phase 1 study

PFS is defined as the time from the start of maintenance treatment to the earliest evidence of disease progression (per RECIST v1.1), or death from any cause

DCR is defined as the proportion of patients achieving complete response, partial response or having stable disease

ORR is defined as the proportion of patients achieving complete response or partial response

OS is defined as the time from randomized to death from any cause or to last contact

Adverse events assessments are computed and categorized according to the Common Toxicity Criteria of the National Cancer Institute, version 5.0

Chinese Academy of Medical Sciences

Professor

Fruquintinib, 4mg/d, qd po, 2 weeks on, 1 week off; Capecitabine: 825mg/m2, bid po, 2 weeks on, 1 week off

Zhigang Bai

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.

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.

A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy

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

ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1

OS is determined from the date of treatment to death from any cause or the last follow-up date

PFS is determined from the date of treatment to PD or death from any cause

DCR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1

Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.

Quality of life is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fruquintinib Plus Capecitabine as Maintenance Treatment of RAS / BRAF Wild-type Metastatic Colorectal Cancer	NCT05016869	Metastatic Colo...	fruquintinib pl...	18 Years - 75 Years	ChineseAMS
A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy	NCT04866108	Unresectable Me...	fruquintinib pl...	18 Years -	Beijing Friendship Hospital

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