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Colorectal CancerPhase 2ALTER-C-002NCT04080843

Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type mCRC Patients

A Phase 2 study testing Anlotinib Hydrochloride, Capecitabine and Oxaliplatin in people with Colorectal Cancer and RAS and BRAF Wild-type, run by Zhejiang University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Anlotinib Hydrochloride, Capecitabine and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesChina
Study dates
15 Nov 2019to 1 Jul 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310000

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

Other trials in China

About this study

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

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

Read the 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.

Being tested
Anlotinib Hydrochloride, Capecitabine, Oxaliplatin
Medical subject headings
Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anlotinib HydrochlorideDrug

    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.

  • CapecitabineDrug

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

  • OxaliplatinDrug

    Oxaliplatin 130 mg/m2,D1

Study groups in NCT04080843
Study groupRoleWhat they receive
Group AExperimentalPatients 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.
Receives: Drug: Anlotinib Hydrochloride; Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate(ORR)

    using RECIST version 1.1

    Measured: 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 outcomes (4)

  1. Progression-free survival (PFS)

    using RECIST version 1.1

    Measured: 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

  2. Disease control rate (DCR)

    using RECIST version 1.1

    Measured: 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

  3. Duration of Response (DoR)

    using RECIST version 1.1

    Measured: 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

  4. 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

    Measured: from day 1 of first dosing to 30 days after permanent discontinuation of Anlotinib

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start15 Nov 2019
  3. Primary completion1 Jun 2022
  4. Study completion1 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04080843
Sponsor's protocol ID
ALTER-C-002
Acronym
ALTER-C-002
Status last verified
Jul 2022
First submitted
3 Sep 2019
Last updated
13 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu Y, Xiao Q, He J, Hu H, Du J, Zhu Y, Chen J, Liu Z, Wang J, Sun L, Xu D, Li J, Liao X, Wang J, Cai Y, Cai C, Jin Z, Wang L, Yuan Y, Ding K. Phase II study of anlotinib in combination with oxaliplatin and capecitabine for patients with RAS/BRAF wild-type metastatic colorectal adenocarcinoma as the first-line therapy. BMC Med. 2022 May 6;20(1):155. doi: 10.1186/s12916-022-02357-6.

    PubMed 35513832

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib Hydrochloride, Capecitabine and Oxaliplatin in people with Colorectal Cancer and RAS and BRAF Wild-type, run by Zhejiang University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04080843, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.

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