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Colorectal CancerPhase 2NCT03397199

Study of Apatinib Plus S-1 as the Therapy of Advanced Colorectal Cancer

A Phase 2 study testing Apatinib + S-1 in people with Colorectal Cancer, run by Henan Cancer Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to confirm the safety and efficacy of Apatinib plus S-1 as the Therapy of Advanced Colorectal Cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Apatinib + S-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
9 Jan 2018to Mar 2021
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

  • Signed the informed consent form prior to patient entry.
  • Histologically or cytologically diagnosed as metastatic colon or rectal adenocarcinoma patients.
  • The second-line standard regimen failed (disease progression) and the chemotherapy regimen included fluorouracil (5-FU / capecitabine / tioguanide), oxaliplatin and irinotecan from the last chemotherapy> 14 days.
  • ≥ 18 and ≤ 70 years of age.
  • Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
  • Life expectancy of more than 3 months.
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  • According to the solid tumor efficacy evaluation criteria RECISTv1.1 standards, at least one measurable lesions. If the previous treatment of local treatment (radiotherapy, radiofrequency, intervention, etc.) is the only focus of lesions, the request must have a clear imaging progress.
  • Adequate hepatic, renal, heart, and hematologic functions: ANC ≥1.5×109/L, PLT ≥ 100×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr≤ 1.5×ULN, Cr clearance ≥ 60 mL/min.
  • Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 6 months after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 6 months after last dose of study drug.

Who cannot join

  • Uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy).
  • Poor glycemic control in diabetes.
  • Acute cerebral infarction, or recovery period <2 months.
  • A variety of factors that affect oral absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).
  • Patients with gastrointestinal bleeding risk may not be included, including the following: (1) active peptic ulcer lesions and fecal occult blood (++); (2) history of melena and vomiting within 3 months；Fecal occult blood (+) is not an exclusion criterion.
  • Coagulation dysfunction (INR> 1.5, PT> ULN + 4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
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  • Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g.
  • Pregnant or lactating women.
  • Cytotoxic drug treatment, radiotherapy within 2 weeks after treatment; had taken two or more oral targeted drugs.
  • Other malignant tumors, cutaneous basal cell carcinoma, and cervical cancer in situ in the past 5 years.
  • The investigators believe there is any condition that may harm the subject or result in the subject's inability to meet or perform the research requirements
  • Severe liver and kidney dysfunction (grade 4) patients should be excluded.
  • Any allergy to apatinib should be excluded.
  • Persons with a history of substance abuse who can not be abdicated or have mental disorders.
  • Previously used regurgitine is not an exclusion criterion.
  • According to the judgment of the researcher, there is a concomitant disease that seriously endangers the patient's safety or affects the patient in completing the study.
  • Patients who underwent surgery within 4 weeks prior to the start of treatment or who had major trauma or fractures. Or there is an unhealed wound before treatment.
  • Patients with severe heart disease such as grade III or above (NYHA standard) congestive heart failure, grade III or above (CCS standard) angina, or a history of myocardial infarction within 6 months prior to the start of treatment, or patients requiring medication Arrhythmia.
  • A brain metastasis, meningeal transfer.
  • Active HBV infection and refusal of regular antiviral treatment.
  • Active tuberculosis patients.
  • Participate in any drug or medical device clinical trial within 1 month before the test.

Trial locations and contacts

1 site in 1 country.

Ning Li contact

13526501903

lining97@126.com

China1 site, 1 recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Ning Li

    Recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Trial of Apatinib Plus S-1 as the Therapy of Advanced Colorectal Cancer

The purpose of this study is to confirm the safety and efficacy of Apatinib plus S-1 as the Therapy of Advanced Colorectal Cancer.

Read the detailed description

Colorectal cancer is a common clinical gastrointestinal cancer. In addition to the early diagnosis of some patients, approximately 50% of patients have had distant metastases at the time of diagnosis. For patients with advanced colorectal cancer, systemic chemotherapy is the main treatment. We consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients. We designed the study to explore the possibility of apatinib for Advanced Colorectal Cancer.

Being tested
Apatinib + S-1
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Apatinib + S-1Drug

    Apatinib 250mg/d,q.d.,p.o. A course of treatment need 21days. S-1 40-60mg（40mg bid BSA <1.4, 60mg bid BSA>1.4），bid,from day1-day 14.

Study groups in NCT03397199
Study groupRoleWhat they receive
Apatinib + S-1ExperimentalApatinib + S-1
Receives: Drug: Apatinib + S-1

What is being measured

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

  1. Progression-free Survival (PFS)

    From date of randomization until the date of first documented progression or date of death from any cause

    Measured: up to 2 year

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    From date of randomization until the date of death from any cause

    Measured: up to 1 year

  2. Disease Control Rate (DCR)

    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR

    + PR + SD)

    Measured: up to 1 year

  3. Overall survival(OS)

    From date of randomization until the date of death from any cause

    Measured: up to 2 year

Timeline

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

  1. First posted11 Jan 2018
  2. Study start9 Jan 2018
  3. Primary completionOct 2020 (estimated)
  4. Study completionMar 2021 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03397199
Sponsor's protocol ID
AHEAD-HNP052
Status last verified
Apr 2020
First submitted
5 Jan 2018
Last updated
15 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li N, Deng W, Zhang G, Du Y, Guo Y, Ma Y, Wei C, Bie L, Zhang C, Song T, Luo S, Fang B. Low-Dose Apatinib Combined With S-1 in Refractory Metastatic Colorectal Cancer: A Phase 2, Multicenter, Single-Arm, Prospective Study. Front Oncol. 2021 Sep 2;11:728854. doi: 10.3389/fonc.2021.728854. eCollection 2021.

    PubMed 34540697

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib + S-1 in people with Colorectal Cancer, run by Henan Cancer Hospital 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 22 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 15 Apr 2020. 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 Ning Li (13526501903, lining97@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: up to 2 year). 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 NCT03397199, 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 15 Apr 2020.

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