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Gastric CancerPhase 2NCT03144843

Apatinib Combined With Paclitaxol as Second Line Therapy for Advanced Gastric Cancer.

A Phase 2 study testing Apatinib in people with Gastric Cancer, run by Sun Yat-sen University at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 multicenter, randomized, double-blind study will evaluate the efficacy and safety of apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
Apatinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
2 sitesChina
Study dates
13 Jan 2017to 31 Jan 2020
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

  • Adult patients, aged between 18 and 75 years old;
  • Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ;
  • At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1); and confirmed as peritoneal metastasis by CT scan or laparoscope
  • Patients must have received one prior chemotherapy regimen for AGC;First-line therapy must have included a combination of at least a platinum-based treatment given concurrently, and must have experienced disease progression during or after first-line therapy for their disease;
  • Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
  • Life expectancy of more than 3 months;
  • Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More than 4 weeks for other cytotoxic agents, operation or radiotherapy;
  • Adequate hepatic, renal, heart, and hematologic functions ( hemoglobin≥ 90g/L, platelets ≥ 80 × 10*9/L, neutrophil ≥1.5 × 10*9/L, serum creatinine≤ 1.5mg/dl, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN)

Who cannot join

  • Pregnant or lactating women;
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
  • Prior chemotherapy regimen have included taxane (docetaxel or paclitaxel); 4. Uncontrolled hypertension;
  • 5. Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure; 6. Urine protein>grade 1; 7. Any factors that influence the usage of oral administration; 8. Patients with a clear tendency of gastrointestinal bleeding; 9. Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN); 10. Abuse of alcohol or drugs; 11. Less than 4 weeks from the last clinical trial; 12. Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy; 13. Evidence of central nervous system(CNS) metastasis; 14. Disability of serious uncontrolled intercurrence infection.

Trial locations and contacts

2 sites in 1 country.

China2 sites, 2 recruiting

  • Foshan people's Hospital

    Foshan, Guangdong

    Wei Wang, 075783161035, m18038863618@163.com

    Recruiting

  • Cancer center of Sun Yat-sen University

    Guangzhou, Guangdong, 510060

    Fenghua Wang, MD, PhD, 86-020-87342490, wangfh@sysucc.org.cn

    Miao-Zhen Qiu, MD, PhD, 86-020-87342490, qiumzh@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase II Multicenter, Randomized, Double-blind Study of Apatinib Combined With Paclitaxol Versus Placebo With Paclitaxol as Second Line Therapy for Advanced Gastric / Esophagogastric Junction Adenocarcinoma With Peritoneal Metastasis.

This multicenter, randomized, double-blind study will evaluate the efficacy and safety of apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis.

Patients will be randomized to one treatment arm: Arm A: apatinib 500mg qd, Paclitaxol 80mg/m2, d1, d8, d15,every 4 weeks ; Arm B: placebo 500mg qd, Paclitaxol 80mg/m2, d1, d8, d15,every 4 weeks ; Tumor assessment will be done every 8 weeks according to RECIST 1.1. The primary endpoint is progression free survival (PFS).

Read the detailed description

Gastric cancer is the second most common cause of cancer-related deaths worldwide, and most patients are diagnozed at advanced stage in China. Peritoneal metastasis is the most common metastatic site. For gastric cancer patients with peritoneal metastasis, chemotherapy can bring survival benefit versus best sportive care. Paclitaxol is the standard second line chemotherapy for advanced gastric cancer patients.

Apatinib mesylate is a small-molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor (TKI). It has been approved as third-line treatment for patients with advanced gastric adenocarcinoma in China.

This multicenter, randomized, double-blind study will evaluate the efficacy and safety of apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis.

Conditions
Gastric Cancer
Being tested
Apatinib, Placebos
Keywords
Gastric cancer, Peritoneal metastasis, Paclitaxol, Apatinib, Second-line chemotherapy
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • ApatinibDrug

    Also called Paclitaxol

    Apatinib 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks

  • PlacebosDrug

    Also called Paclitaxol

    Placebo: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks

Study groups in NCT03144843
Study groupRoleWhat they receive
Experimental groupExperimentalApatinib: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
Receives: Drug: Apatinib
Placebo groupPlacebo comparatorPlacebo: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
Receives: Drug: Placebos

What is being measured

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

  1. Progression-free survival (PFS)

    The time from randomize to progression or death

    Measured: Approximately 1 year

Secondary outcomes (4)

  1. Overall survival (OS)

    The time from randomize to death

    Measured: Approximately 3 years

  2. Objective response rate (ORR)

    The rate of complete response and partial response according to RECIST guidelines

    Measured: Approximately 1 year

  3. Disease control rate(DCR)

    The rate of complete response , partial response and stable disease according to RECIST guidelines

    Measured: Approximately 1 year

  4. Safety (incidence of adverse events) [

    Incidence of adverse events

    Measured: Approximately 1 year

Timeline

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

  1. First posted9 May 2017
  2. Study start13 Jan 2017
  3. Primary completion31 Jan 2020 (estimated)
  4. Study completion31 Jan 2020 (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
Multicenters ramdomized double-blind phase II study.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03144843
Sponsor's protocol ID
Apatinib_GC
Status last verified
May 2017
First submitted
5 May 2017
Last updated
9 May 2017
Results posted
No
Data monitoring committee
No
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 Apatinib in people with Gastric Cancer, run by Sun Yat-sen University at 2 sites 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 8 inclusion and 4 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 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Approximately 1 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 NCT03144843.

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 May 2017.

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