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Apatinib CombinedPhase 2NCT03192735

Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer

A Phase 2 study testing ApatinibMesylateTablets in people with Apatinib Combined and SOX, run by Chang-Ming Huang, Prof. 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 The sponsor has not verified this record for over two years, so it may be out of date.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

We star a multicentre, one-armed, clinical pilot trial intends to investigate the safety and effectiveness of Apatinib Combined With Oxaliplatin, Gimeracil and Oteracil Porassium Capsules Neoadjuvant Ttherapy for Locally Advanced Gastric Cancer(cT2-4/N+M0) Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Apatinib Combined, SOX, Neoadjuvant Therapy
What is being tested?
ApatinibMesylateTablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Sep 2017to 11 Dec 2024
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

  • Age from 18 to 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT2-4N+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  • No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
  • Performance status of 0 or 2 on Eastern Cooperative Oncology Group scale (ECOG)
  • Without previous surgical, chemotherapy,radiotherapy, immunotherapy, or targeted therapy for gastric cancer.
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  • Estimate life is equal or greater than 3 months
  • No serious heart, lung, liver dysfunction;no Jaundice and obstruction of the digestive tract; no acute infection
  • The main organ function is normal,and meet the following criteria:
  • blood routine examination( No blood transfusion within 14 days)
  • HB≥100g/L，
  • WBC≥3.5×109/L
  • ANC≥1.5×109/L，
  • PLT≥100×109/L；
  • blood biochemical examination
  • BIL <1.5 Upper Limit Of Normal（ULN），
  • ALT and AST<2.5ULN，GPT≤1.5×ULT；
  • Cr≤1ULN，creatinine clearance>60ml/min（Cockcroft-Gault formula）
  • Written informed consent

Who cannot join

  • Pregnant and lactating women
  • Suffering from severe mental disorder
  • History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
  • History of previous chemotherapy or radiotherapy therapy
  • History of other malignant disease within the past 5 years
  • History of previous neoadjuvant chemotherapy or radiotherapy
Show all 14Show fewer
  • History of unstable angina or myocardial infarction within the past 6 months
  • History of cerebrovascular accident within the past 6 months
  • History of continuous systematic administration of corticosteroids within 1 month
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • Patients with a clear tendency of gastrointestinal bleeding,such as: active ulceration,fecal occult blood test(++),The history of hematemesis and melena within 2 months,coagulation disorders(INR>1.5、APTT>1.5 ULN).
  • Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content>1.0g)
  • There are several factors that affect oral medicine,such as unable to swallow, uncontrollable nausea and vomitin, or chronic diarrhea and intestinal obstruction
  • Drug allergy to experimental medicine

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000

Other trials in China

About this study

Official title: Apatinib Combined With Oxaliplatin and Gimeracil and Oteracil Porassium Capsules Neoadjuvant Therapy for Locally Advanced Gastric Cance: A Multicentre, One-armed, Clinical Pilot Trial

We star a multicentre, one-armed, clinical pilot trial intends to investigate the safety and effectiveness of Apatinib Combined With Oxaliplatin, Gimeracil and Oteracil Porassium Capsules Neoadjuvant Ttherapy for Locally Advanced Gastric Cancer(cT2-4/N+M0)

Being tested
ApatinibMesylateTablets

What participants receive

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

  • ApatinibMesylateTabletsDrug

    Also called Oxaliplatin for Injection, Gimeracil and Oteracil Porassium Capsules

    Subject will be given ApatinibMesylateTablets 500mg/per day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 /per day，ivgtt，in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.

Study groups in NCT03192735
Study groupRoleWhat they receive
Apatinib Combined With SOXExperimentalIn this group,subject will be given ApatinibMesylateTablets 500mg one time a day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 one time a day，ivgtt，in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.
Receives: Drug: ApatinibMesylateTablets

What is being measured

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

  1. Radical surgical resection rate

    Radical surgical resection rate is defined as the rate of R0 resection

    Measured: 30 days

Secondary outcomes (8)

  1. Pathological response rate

    Briefly, pathCR (Pathological complete rate) was defined as an absence of carcinoma cells in the primary site, and pathologic partial response (pathPR) was defined as less than 10% residual carcinoma cells in the specimen.

    Measured: 30 days

  2. overall response rate

    according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

    Measured: 30 days

  3. 5-year overall survival rate

    Measured: 60 months

  4. 5-year disease free survival rate

    Measured: 60months

  5. overall postoperative morbidity rates

    Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.

    Measured: 30 days

  6. Duration of postoperative hospital stay

    Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

    Measured: 30 days

  7. 30 days mortality rates

    Defined as the event observed within 30 days after surgery.

    Measured: 30 days

  8. adverse event

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

    Measured: 60 months

Timeline

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

  1. First posted20 Jun 2017
  2. Study start1 Sep 2017
  3. Primary completion11 Nov 2019
  4. Study completion11 Dec 2024 (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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03192735
Sponsor's protocol ID
2017YF004-03
Status last verified
Feb 2020
First submitted
18 Jun 2017
Last updated
5 Feb 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lin JX, Xu YC, Lin W, Xue FQ, Ye JX, Zang WD, Cai LS, You J, Xu JH, Cai JC, Tang YH, Xie JW, Li P, Zheng CH, Huang CM. Effectiveness and Safety of Apatinib Plus Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer: A Nonrandomized Controlled Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116240. doi: 10.1001/jamanetworkopen.2021.16240.

    PubMed 34241629

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ApatinibMesylateTablets in people with Apatinib Combined and SOX, run by Chang-Ming Huang, Prof. 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 19 inclusion and 14 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 5 Feb 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?

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?

Radical surgical resection rate (time frame: 30 days). 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 NCT03192735, 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 5 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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