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Metastatic Colorectal CancerPhase 2NCT03210064

Clinical Study of Apatinib and 5-Fu Combination Regimen to Treat Advanced Colorectal Cancer Patients

A Phase 2 study testing Apatinib and 5-fluorouracil in people with Metastatic Colorectal Cancer, run by Hui ting Xu，MD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study makes an observation over the objective response rate of Apatinib and 5-Fu combination regimen in the three-line treatment of metastatic colorectal cancer. All the participants will randomly receive the treatment of Apatinib and 5-Fu combination regimen or 5-Fu. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Apatinib and 5-fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
4 May 2017to 24 Apr 2019
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 and ≤ 70 years of age
  • Histological confirmed advanced or metastatic colorectal Cancer，at least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
  • Have failed for ≥ 2 lines of chemotherapy
  • Life expectancy of more than 3 months
  • ECOG performance scale ≤ 1
  • Duration from the last therapy is more than 6 weeks for nitroso or mitomycin More than 4 weeks for operation, radiotherapy or cytotoxic agents
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  • Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 × 10E+9/L, neutrophil > 1.5 × 10E+9/L, serum creatinine ≤ 1×upper limit of normal(ULN), bilirubin < 1.25 ULN, and serum transaminase ≤ 2.5× ULN)
  • Child bearing potential, a negative urine or serum pregnancy test result before initiating apatinib, must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article.
  • Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Who cannot join

  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Pregnant or lactating women
  • Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy, more than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥ 470 ms), or cardiac insufficiency myocardial ischemia, arrhythmia, or cardiac insufficiency
  • Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Any factors that influence the usage of oral administration Evidence of CNS metastasis
  • URT: urine protein ≥ (++)and > 1.0 g of 24 h
Show all 13Show fewer
  • PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation
  • Abuse of drugs
  • Certain possibility of gastric or intestine hemorrhage
  • Less than 4 weeks from the last clinical trial
  • Viral hepatitis type B or type C
  • Prior VEGFR inhibitor treatment
  • Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study

Trial locations and contacts

1 site in 1 country.

Hui ting XU contact

15307176219 ext. 86

2891533@qq.com

Hong li XU contact

13554458191 ext. 86

xu2010ky@163.com

China1 site, 1 recruiting

  • Hui ting Xu

    Wuhan, Hubei, 027

    Hui ting XU, MD, 15307176219 ext. 86, 2891533@qq.com

    Recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Trial Study on Apatinib and 5-Fu Combination Regimen in the Treatment of Advanced Colorectal Cancer Patients

This study makes an observation over the objective response rate of Apatinib and 5-Fu combination regimen in the three-line treatment of metastatic colorectal cancer. All the participants will randomly receive the treatment of Apatinib and 5-Fu combination regimen or 5-Fu.

Read the detailed description

5-Fu chemotherapy is an effective therapy for colorectal cancer. Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular endothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. A phase II trail of Apatinib has been demonstrated that Apatinib is safe to treat the metastatic colorectal cancer and the disease control rate can reach 50%.

Keywords
Apatinib
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • ApatinibDrug

    Also called 5-fluorouracil

    Apatinib Mesylate Tablets 500 mg qd po

  • 5-fluorouracilDrug

    Also called 5-Fluorouracil derivatives

    5-Fluorouracil 400mg/m2 iv d1，2400mg-3000mg/m2 civ 46h,q2w.5-Fluorouracil derivatives(Capecitabine 1000mg/m2 bid po d1-d14 q3w.S1 40mg/m2 bid po d1-d14 q3w).

Study groups in NCT03210064
Study groupRoleWhat they receive
Apatinib and 5-FluorouracilExperimentalApatinib 500 mg qd po.5-Fluorouracil 400mg/m2 iv d1，2400mg-3000mg/m2 civ 46h,q2w.5-Fluorouracil derivatives(Capecitabine 1000mg/m2 bid po d1-d14 q3w.S1 40mg/m2 bid po d1-d14 q3w).
Receives: Drug: Apatinib; Drug: 5-fluorouracil
5-FluorouracilActive comparator5-Fluorouracil 400mg/m2 iv d1，2400mg-3000mg/m2 civ 46h,q2w.5-Fluorouracil derivatives(Capecitabine 1000mg/m2 bid po d1-d14 q3w.S1 40mg/m2 bid po d1-d14 q3w).
Receives: Drug: 5-fluorouracil

What is being measured

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

  1. ORR

    The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.

Secondary outcomes (4)

  1. DCR

    DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD)

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.

  2. PFS

    PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.

  3. OS

    OS is defined as the time from date of assignment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

    Measured: From assignment of the first subject until 30 death events observed, up to 2 years.

  4. QoL

    The general well-being of participants, outlining negative and positive features of life.

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.

Timeline

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

  1. First posted6 Jul 2017
  2. Study start4 May 2017
  3. Primary completion24 Apr 2018 (estimated)
  4. Study completion24 Apr 2019 (estimated)

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
Randomised
Intervention model
Parallel groups
Model description
Experimental: apatinib combined with 5-Fu
Masking
Single blind
Who is masked
Participant
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03210064
Sponsor's protocol ID
HXu
Status last verified
Jul 2017
First submitted
15 May 2017
Last updated
6 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen R, Yang L, Hu S, Yin Z, Nie Y, Xu H, Zhong Y, Zhu Y, Liang X, Xu H. Apatinib plus 5-fluorouracil as a third or subsequent-line treatment option for metastatic colorectal cancer: a phase-II, single-arm, prospective study. Ann Transl Med. 2022 Jan;10(2):100. doi: 10.21037/atm-22-77.

    PubMed 35282086

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib and 5-fluorouracil in people with Metastatic Colorectal Cancer, run by Hui ting Xu，MD at 1 site 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 9 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: status not confirmed, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Hui ting XU (15307176219 ext. 86, 2891533@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: From assignment of the first subject to 3 months later after the last participant is recruited.). 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 NCT03210064, 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 6 Jul 2017.

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