Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04080843
Recruitment Status : Not yet recruiting
First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Information provided by (Responsible Party):
Ding Ke-Feng, Zhejiang University

Brief Summary:

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. 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


Condition or disease Intervention/treatment Phase
Colorectal Cancer RAS and BRAF Wild-type Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Drug: Anlotinib Hydrochloride Drug: Capecitabine Drug: Oxaliplatin Phase 2

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. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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.

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04080843


Contacts
Layout table for location contacts
Contact: Kefeng Ding, PhD 13906504783 dingkefeng@zju.edu.cn

Locations
Layout table for location information
China, Zhejiang
The Second Affiliated Hospital of Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Kefeng Ding, PhD    13906504783    dingkefeng@zju.edu.cn   
Zhejiang Cancer Hospital Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Jieer Ying, PhD         
Sponsors and Collaborators
Zhejiang University
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Layout table for additonal information
Responsible Party: Ding Ke-Feng, Clinical professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT04080843     History of Changes
Other Study ID Numbers: 2019268
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Digestive System Neoplasms
Digestive System Diseases
Colorectal Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Site
Intestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents