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Gastric CancerPhase 1NCT03276156

Apatinib in Combination With S-1 as Second-Line Treatment in Patients With Advanced Gastric Cancer

A Phase 1 study testing Apatinib plus S-1 in people with Gastric Cancer, run by Zhejiang 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 The sponsor has not verified this record for over two years, so it may be out of date.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 determine the maximum tolerated dose (MTD)and safety of Apatinib combined with S-1 as Second-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Apatinib plus S-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
23 Feb 2016to 22 Feb 2018
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fully informed consent prior to any specific research procedure.
  • Adult patients, aged ≥18 years;
  • Imaging test confirmed the progression after first-line treatment of advanced gastric adenocarcinoma or Gastroesophageal Junction Adenocarcinoma.
  • S-1 was not used in the first-line treatment
  • If patient relapse in 6 months after adjuvant chemotherapy or neoadjuvant chemotherapy, the adjuvant chemotherapy or neoadjuvant chemotherapy was regarded as the first-line treatment.
  • Adjuvant chemotherapy or neoadjuvant chemotherapy was allowed if the first-line treatment started beyond 6 months after the end of previous treatment.
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  • During the research ,patient should be willing and be able to follow the process treatment ,follow up and tests.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
  • Survival expectation ≥ 16 weeks from the planned first dosing .
  • During the 28 days prior to the first dosing, hematological, biochemical and Organ Functions:HB ≥ 9.0 g/dL, ANC ≥ 1.5×109/L,WBC>3×109/L， PLT ≥ 100×109/L, BIL < 1.5×ULN, ALT or AST < 2.5×ULN (or < 5×ULN in patients with liver metastases), Serum Cr ≤ 1.5×ULN;
  • Lesions ,measurable and/or unmeasurable,at least one,can be assessed by imaging during the baseline and follow-up measurement.
  • Localized mass in gastric or Gastroesophageal Junction belongs to unmeasurable Lesions.
  • Women, those postmenopausal or of child-bearing age, but the pregnancy test results (serum or urine) within 28 days before treatment is negative, and the results should be confirmed in day 1 of the treatment.
  • Postmenopausal women are defined as :woman's menstrual periods have ceased for 1 year or longer after exogenous hormone therapy;
  • Women, aged>50years,serum LH and FSH level show a postmenopause;
  • Woman has radiation induced ovarian failure,and gone without a period for over 12 consecutive months;
  • Woman has chemotherapy-induced menopause and gone without a period for over 12 consecutive months;
  • sterilization operation( hysterectomy or bilateral oophorectomy)

Who cannot join

  • Has participated in another clinical trial in progress.
  • Has received more than one chemotherapy regimens after disease progression(except for those who has receiced adjuvant chemotherapy or neoadjuvant chemotherapy 6 months or longer)
  • Previous therapy with S-1
  • Has received VEGFR inhibitor, such as Sorafenib,Sunitinib .
  • Has another primary tumor,but adequately treated non-melanoma skin cancer , effectively treated carcinoma in situ of cervix and other well handled cancer over 5 years were not covered.
  • Has difficulty in swallowing
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  • Has taken experimental drugs within 14 days before randomly assign.( For different drug characteristics, the interval can be longer)
  • History of any chemotherapy, radiotherapy,the last administration should finish within 3 weeks prior to trial first drug administration( For different drug characteristics, the interval can be longer). If steady dose of diphosphate or denosumab is necessary for the treatment of bone metastases,the administration should start 3-4weeks prior to the study .
  • Patients with poor-controlled arterial hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than Class I, arrhythmia greater than Class I (including QT interval prolongation, for man > 450 ms, for woman > 470 ms), and cardiac dysfunction greater than Class I;
  • Has persistent toxicity (exclude alopecia )of previous treatment ,CTCAE>1.
  • Has intestinal obstruction or upper gastrointestinal hemorrhage(CTCAE 3 or 4) within 4 weeks prior to randomly assign.
  • Abnormal coagulation function (INR > 1.5×ULN, APTT > 1.5×ULN), with tendency of bleed;
  • Has symptom of brain metastases and the tendency out of control,but imaging confirmed is not required.If steady dose of Glucocorticoid is necessary for the treatment,the administration should be started >4weeks prior to the study . Patients with spinal cord compression received definite treatment and the situation had been proven stable in 28days .
  • Has surgery within 2 weeks prior to the study. Eligible patients should recovered from any major surgery.
  • Subjects that are unable to swallow tablets, chronic diarrhea ,or intestinal obstruction;
  • Subjects with a clear tendency of gastrointestinal bleeding;
  • Pregnant or lactating women;
  • Other conditions regimented at investigators' discretion.

Trial locations and contacts

1 site in 1 country.

Haijun Zhong contact

0571-88122058

ZHJ1712@aliyun.com

China1 site, 1 recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Recruiting

Other trials in China

About this study

Official title: Apatinib in Combination With S-1 as Second-Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

The purpose of this study is to determine the maximum tolerated dose (MTD)and safety of Apatinib combined with S-1 as Second-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma.

Conditions
Gastric Cancer
Being tested
Apatinib plus S-1
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Apatinib plus S-1Drug

    Drug:Apatinib (425 mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (500 mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (675mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (750 mg/d) + S-1 (80mg to 120 mg);

Study groups in NCT03276156
Study groupRoleWhat they receive
Apatinib plus S-1ExperimentalApatinib (425/500/675/750mg,qd,p.o.) concomitantly with S-1 (80mg to 120 mg, qd,days1-14, q3w, p.o.)
Receives: Drug: Apatinib plus S-1

What is being measured

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

  1. Progression Free Survival(PFS)

    Measured: Event driven, an expected average of 4 months

  2. Incidence of adverse events

    Measured: An expected average of 4 months

Secondary outcomes (4)

  1. Overall survival(OS)

    Measured: An expected average of 12months

  2. Disease control rate(DCR)

    Measured: An expected average of 4 months

  3. Objective response rate(ORR)

    Measured: An expected average of 4 months

  4. Quality of life(QoL)

    Measured: An expected average of 12 months

Timeline

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

  1. First posted8 Sep 2017
  2. Study start23 Feb 2016
  3. Primary completion22 Feb 2018 (estimated)
  4. Study completion22 Feb 2018 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03276156
Sponsor's protocol ID
Ahead-G001
Status last verified
May 2017
First submitted
6 Sep 2017
Last updated
8 Sep 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Apatinib plus S-1 in people with Gastric Cancer, run by Zhejiang 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 18 inclusion and 18 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 8 Sep 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Haijun Zhong (0571-88122058, ZHJ1712@aliyun.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: Event driven, an expected average of 4 months). The study lists 2 primary outcomes in all. 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 NCT03276156.

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 8 Sep 2017.

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