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Metastatic Gastric CancerPhase 2NCT03154983

The Clinical Research of Mesylate Apatinib Combined With Docetaxel and S-1 as the First-line Treatment of Metastatic Gastric Cancer

A Phase 2 study testing docetaxel in people with Metastatic Gastric Cancer, run by Zhou Fuxiang 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 The sponsor has not verified this record for over two years, so it may be out of date.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 evaluate the efficacy and safety of Apatinib Mesylate Tablets combined with docetaxel and S-1 as the first-line treatment of metastatic gastric cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Metastatic Gastric Cancer
What is being tested?
docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
20 May 2017to 31 Dec 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-70 years of age;
  • recurrent or metastatic adenocarcinoma of the stomach or gastroesophageal junction diagnosed by pathology (including histology or cytology);
  • 1 measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST(Response Evaluation Criteria In Solid Tumors）1.1;
  • had not received other anti VEGFR targeted therapy;
  • ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-2 scores;
  • the expected survival time is more than 3 months;
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  • if patient had accepted the chemotherapy, the time from the last chemotherapy should be more than 6 months;
  • the damage caused by other treatments has been restored, and the subjects received radiotherapy or surgery over 4 weeks ago, and the wound has healed completely;
  • the main organ function is normal, which should meet the following criteria: (1) blood routine examination standards should be met: (no blood transfusion within 14 days) A. HB（hemoglobin） = 90g/L, B. ANC(absolute neutrophil count) = 1.5 * 109/L, C. PLT（platelet） = 80 * 109/L; (2) biochemical examination shall comply with the following criteria: A. BIL（bilirubin） <1.25 normal upper limit (ULN), B. ALT（glutamic-pyruvic transaminase） and AST（glutamic-oxalacetic transaminase）<2.5ULN（upper limit of normal）, if subjects have liver metastases, the ALT and AST <5ULN（upper limit of normal）, C. Cr ≤ 1ULN, CCR（creatinine clearance rate） > 50ml/min (Cockcroft-Gault formula);
  • women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test;
  • participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.

Who cannot join

  • Suffering from other malignant tumors previously or at the same time, with the exception of cured skin basal cell carcinoma and cervical carcinoma in situ;
  • Patients have used the paclitaxel class and / or S-1 as the adjuvant therapy in 2;
  • have been confirmed to be allergic to docetaxel, 5-fluorouracil, apatinib and / or its accessories;
  • the blood pressure of patients with hypertension cannot be reduced to the normal range by the antihypertensive drugs (systolic pressure >140 mmHg, diastolic pressure >90 mmHg);
  • patients are suffering from severe cardiovascular disease: the II level of myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc(corrected QT interval) prolongation of male > 450 ms, of female > 470ms ); and patients have III-IV grade of cardiac insufficiency, or left ventricular (LVEF) < 50% shown by echocardiography according to the NYHA(New York Heart Association) standard;
  • patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative >1.0g);
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  • have a variety of factors that affect oral drugs (such as difficulty in swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
  • patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and unresected gastric primary tumor; patients with the risk of bleeding should take the gastroscopy test, if it is the gastric cancer, and researchers believe that may results in massive digestive tract hemorrhage;
  • coagulation dysfunction (INR(international normalized ratio)>1.5, APTT(activated partial thromboplastin time)>1.5 ULN), with bleeding tendency;
  • patients with a history of psychotropic substance abuse and unable to give up or have mental disorders;
  • Patients who participated in other clinical trials within 4 weeks;
  • have received the VEGFR inhibitors, such as sorafenib and sunitinib;
  • according to the researcher's judgment, there are other accompanying disease endangering the patient's safety or affect the patient to complete the study.
  • patients with central nervous system metastasis;
  • pregnant or lactating women;
  • the researchers consider those who were not suitable for inclusion.

Trial locations and contacts

1 site in 1 country.

Ling Xia, M.D. contact

18971250716

82425583@qq.com

China1 site, 1 recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

    Fuxiang Zhou, M.D., 18971252780, happyzhoufx@sina.com

    Ling Xia, M.D., 18971250716, 22425583@qq.com

    Recruiting

Other trials in China

About this study

The purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate Tablets combined with docetaxel and S-1 as the first-line treatment of metastatic gastric cancer.

Being tested
docetaxel
Keywords
Mesylate Apatinib, The First-line Treatment, Metastatic Gastric Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • docetaxelDrug

    Also called Tegafur, Mesylate Apatinib

    Diagnosed with metastatic gastric cancer patients (including the esophagogastric junction adenocarcinoma), DS(docetaxel and Tegafur)and Mesylate apatinib 6 cycles, the specific amount of usage: DS Docetaxel 75mg/m2 D1 IV.drop 1H（one hour）, Tegafur(BSA<1.25 40mg Po bid(twice a day), BSA >=1.25-<1.5 50mg Po bid, BSA >=1.5 60mg Po bid, Q21d(21 days a cycle)); Mesylate Apatinib 500mg Po QD（once a day)） continuous use, until disease deterioration.

Study groups in NCT03154983
Study groupRoleWhat they receive
First-line treatmentExperimentalFirst-line treatment：treatment including Mesylate Apatinib Combined With Docetaxel and S-1(DS).DS Docetaxel 75mg/m2 d1 iv.drop 1h（one hour）， S-1(BSA<1.25 40mg Po bid(twice a day), BSA >=1.25-<1.5 50mg Po bid, BSA >=1.5 60mg Po bid), Q21d(21 days a cycle); Mesylate Apatinib 500mg Po QD(once a day) continuous use; until disease deterioration.
Receives: Drug: docetaxel

What is being measured

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

  1. progress-free survival time

    During the treatment, the investigators will arrange patients to underwent CT and MRI examination on time, evaluating the size and the number of the tumor, to determine whether the disease progress than before; and the time from the start of treatment to the progression is progress-free survival time.

    Measured: 30 months

Secondary outcomes (5)

  1. Overall survival Time

    During and after treatment, all patients were followed up regularly ,the patients will be arranged to evaluate the Performance status score or Karnofsky Performance Score to assess the patient's health and disease controling, until the patient died; the time from the beginning of treatment to death is overall survival time.

    Measured: 30 months

  2. Overall remission Rate

    During the treatment, the investigators will regularly arrange patients to underwent CT, MRI ,Tumor marker examination and so on, evaluating the size and the number of the tumor, utilizing Response Evaluation Criteria in Solid Tumors to assess whether the disease progress than previous; and the percentage of patients with complete remission and partial remission of the disease is Overall remission Rate.

    Measured: during 6 cycles of chemotherapy (each cycle is 28 days)

  3. adverse events

    During and after treatment, the investigators will on the basis of The clinical application expert consensus of Mesylate Apatinib to cure gastric cancer and The evaluation criteria of adverse drug reaction to assess patients who accepted treatment whether has adverse events.

    Measured: up to 28 weeks

  4. Quality of life

    During and after treatment, the investigators will on the basis of The Lancashire Quality of Life Profile to assess the patients' life quality regularly.

    Measured: 30 months

  5. disease control rate

    During the treatment, the investigators will regularly arrange patients to underwent CT, MRI ,Tumor marker examination and so on, to assess the size and the number of the tumor, utilizing Response Evaluation Criteria in Solid Tumors to assess whether the disease progress than previous; and the percentage of patients with disease control is disease control rate.

    Measured: 30 months

Timeline

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

  1. First posted16 May 2017
  2. Study start20 May 2017
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 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
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03154983
Sponsor's protocol ID
HCCSC G04
Status last verified
Dec 2020
First submitted
8 May 2017
Last updated
9 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel in people with Metastatic Gastric Cancer, run by Zhou Fuxiang 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 11 inclusion and 16 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 9 Dec 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 Ling Xia, M.D. (18971250716, 82425583@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progress-free survival time (time frame: 30 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 NCT03154983.

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 9 Dec 2020.

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