A Phase 2 interventional study of Anlotinib Hydrochloride and Capecitabine in Colorectal Cancer, RAS and BRAF Wild-type and Colorectal Neoplasms, sponsored by Zhejiang University. Completed at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-13.
Sponsored by Zhejiang University · Phase 2, Interventional, and Treatment
This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF wild-type patients with Metastatic Colorectal Carcinoma(CRC) as 1st Therapy. After 6 cycles of combined therapy, patients will receive capecitabine and anlotinib as maintenance therapy until tumor progression.In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with CAPEOX in treatment of patients with mCRC. The patients who are pathologically confirmed as RAS and BRAF wild-type mCRC will be enrolled.
Condition or disease Invention/treatment Phase Colorectal Cancer Drug: Anlotinib Hydrochloride Drug: Capecitabine Drug: Oxaliplatin Phase 2
This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF wild-type patients with Metastatic Colorectal Carcinoma(CRC) as 1st Therapy. After 6 cycles of combined therapy, patients will receive capecitabine and anlotinib as maintenance therapy until tumor progression.In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with CAPEOX in treatment of patients with Metastatic Colorectal Carcinoma(mCRC).Primary Efficacy Endpoint: Objective Response Rate (ORR), Secondary Efficacy Endpoints: Progression free survival (PFS) (According to RECIST Version 1.1), Disease Control Rate (DCR) and duration of response(DoR). Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.
Exclusion Criteria:
Patients in the study group will receive the following treatment: 21 days as a treatment cycle, Anlotinib 12 mg/day, Orally(D1-D14); Capecitabine 850 mg/m2,Orally(D1-D14), Bid; Oxaliplatin 130 mg/m2, iv(D1). If anlotinib is not tolerated(except Hand-foot skin reaction), the dose can be reduced to 10mg or 8mg ,until un-tolerable toxicity again. After 6 cycles of combined therapy, patients will receive capecitabine and anlotinib as maintenance therapy until tumor progression.
Drug: Anlotinib Hydrochloride · Drug: Capecitabine · Drug: Oxaliplatin
Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off.
Capecitabine is a capsule in the form of 500 mg, orally, 850 mg/m2, twice daily, 2 weeks on/1 week off.
Oxaliplatin 130 mg/m2,D1
Objective response rate(ORR)
using RECIST version 1.1
Time frame: Every 2 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Progression-free survival (PFS)
using RECIST version 1.1
Time frame: every 2 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Disease control rate (DCR)
using RECIST version 1.1
Time frame: every 2 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Duration of Response (DoR)
using RECIST version 1.1
Time frame: every 2 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Safety: NCI CTC AE Version 4.0.3
Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 4.0.3
Time frame: from day 1 of first dosing to 30 days after permanent discontinuation of Anlotinib
Plan to share: No
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Zhejiang University