Abstract 469P
Background
For unresectable RAS/BRAF wild-type metastatic colorectal cancer (mCRC), standard first-line treatments are anti-VEGF or anti-EGFR monoclonal antibodies plus chemotherapy. Anlotinib is an oral small molecule inhibitor of multiple receptor tyrosine kinases, including VEGF receptors 1/2/3, FGF receptors 1-4, PDGF receptors α/β and c-Kit, with a broad inhibitor of tumor angiogenesis and growth. The primary aim of ALTER-C-002 trial is to investigate the efficacy and safety of Anlotinib combined with CAPEOX as first-line treatment for unresectable mCRC.
Methods
In this single-arm, multi-center phase II clinical trial, 30 patients with unresectable mCRC, aged 18-75, without prior systemic treatment and ECOG status ≤ 1 will be prospectively included. Patients received capecitabine (850 mg/m2 PO on day 1-14 every 3 weeks), oxaliplatin (130 mg/m2 IV day 1 every 3 weeks) and Anlotinib (12 mg PO 2 weeks on/1 week off). After 6 cycles of combining therapy, patients will receive capecitabine and Anlotinib as maintenance therapy until tumor progression. Primary endpoint is objective response rate (ORR); secondary endpoints included safety, disease control rate (DCR) and progression-free survival (PFS).
Results
As of 16 May 2020, 10 patients were enrolled. At the time of the pre-planned interim analysis, no patients had discontinued treatment. Among 7 evaluable patients, 6 of them achieved PR and 1 SD. The ORR was 85.71% and DCR was 100%. Grade 3 adverse events included Hypertension(n=5), Leukopenia and neutropenia (n=1), Hyperbilirubinemia (n=1). No grade IV or above AEs occurred.
Conclusions
The study showed preliminary efficiency and safety of first-line anlotinib combined with CAPEOX in unresectable mCRC, which merit further evaluation in randomized studies.
Clinical trial identification
NCT04080843.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.