Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type mCRC Patients (ALTER-C-002)

July 12, 2022 updated by: Ding Ke-Feng, Zhejiang University

An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type Patients With Metastatic Colorectal Carcinoma as 1st Therapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310000
        • The Second Affiliated Hospital of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least one measurable lesion (the length of spiral CT scan (> 10mm) meets the requirements of RESCIST 1.1) is found in patients with HCC confirmed by histopathology or cytology or who meet the clinical diagnostic criteria.
  • ≥ 18 and ≤ 75 years of age
  • ECOG performance status of 0-1
  • No prior treatment for advanced disease (adjuvant therapy allowed)
  • Life expectancy of at least 3 months
  • The main organs are functioning normally.
  • Neutrophils count =/> 1.5 x 109/L, platelets count =/> 100 x 109/L, HGB =/> 90 g/L
  • total bilirubin =/< 1.5 x UNL • SGOT and SGPT =/< 2.5 x UNL (=/< 5 x UNL in patients with liver metastases)
  • Creatinine =/< 1.5 x UNL
  • Patients who are molecularly diagnosed as having RAS and BRAF wild-type mCRC are Histologically/cytologically confirmed as advanced, colorectal cancer.
  • Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.
  • Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg), patients with myocardial infarction, arrhythmias with poor control (including QTC interval > 450 ms) and cardiac insufficiency of grade II according to NYHA standard.
  • with bleeding tendency or undergoing thrombolysis or anticoagulation therapy.
  • serious uncontrolled intercurrence infection.
  • Proteinuria ≥ 2+ (1.0g/24hr).
  • Have evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness.
  • Within 6 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.
  • Have a history of mental illness or psychotropic drug abuse.
  • Patients with a history of immunodeficiency(or autoimmue disease), or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and hematopoietic stem cell transplantation.
  • Patients who are allergic to components of Capecitabine preparations, Oxaliplatin injection and anlotinib preparations.
  • According to the researchers' judgment, there are serious concomitant diseases that endanger patient safety or prevent patients from completing the study.
  • Patients who have received prior systemic chemotherapy, targeted therapy, immunity therapy or any medication within 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A

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
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.
Drug: Capecitabine
Capecitabine is a capsule in the form of 500 mg, orally, 850 mg/m2, twice daily, 2 weeks on/1 week off.
Drug: Oxaliplatin
Oxaliplatin 130 mg/m2,D1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate(ORR)
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
using RECIST version 1.1
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
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
using RECIST version 1.1
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)
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
using RECIST version 1.1
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)
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
using RECIST version 1.1
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
Time Frame: from day 1 of first dosing to 30 days after permanent discontinuation of Anlotinib
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
from day 1 of first dosing to 30 days after permanent discontinuation of Anlotinib

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 15, 2019

Primary Completion (ACTUAL)

June 1, 2022

Study Completion (ACTUAL)

July 1, 2022

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (ACTUAL)

September 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTER-C-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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