CClinicalTrials.gg
Status unknownNCT03144843Updated May 9, 2017

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

A Phase 2 interventional study of Apatinib and Placebos in Gastric Cancer, sponsored by Sun Yat-sen University. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-05-09.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2017, registered May 2017).
Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Gastric Cancer

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Keywords

  • Gastric cancer
  • Peritoneal metastasis
  • Paclitaxol
  • Apatinib
  • Second-line chemotherapy
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.

This study's planned enrollment of 110 is above the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adult patients, aged between 18 and 75 years old;
  2. Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ;
  3. 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
  4. 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;
  5. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
  6. Life expectancy of more than 3 months;
  7. 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;
  8. 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)

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
  3. Prior chemotherapy regimen have included taxane (docetaxel or paclitaxel); 4. Uncontrolled hypertension;
  1. 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Experimental group

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

    Drug: Apatinib

  • Placebo comparator
    Placebo group

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

    Drug: Placebos

Interventions

  • DrugApatinib

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

    Also known as: Paclitaxol

  • DrugPlacebos

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

    Also known as: Paclitaxol

06

What researchers measure

Primary outcomes

  1. Progression-free survival (PFS)

    The time from randomize to progression or death

    Time frame: Approximately 1 year

Secondary outcomes

  1. Overall survival (OS)

    The time from randomize to death

    Time frame: Approximately 3 years

  2. Objective response rate (ORR)

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

    Time frame: Approximately 1 year

  3. Disease control rate(DCR)

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

    Time frame: Approximately 1 year

  4. Safety (incidence of adverse events) [

    Incidence of adverse events

    Time frame: Approximately 1 year

07

Study locations

2 of 2 sites recruiting
  • Foshan people's Hospital
    Foshan, Guangdong, China
    Recruiting
  • Cancer center of Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03144843
Lead sponsor
Sun Yat-sen University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Fenghua Wang (Professor, Sun Yat-sen University) — Principal investigator
First posted
May 9, 2017
Start date
Jan 13, 2017
Primary completion
Jan 31, 2020 (estimated)
Completion
Jan 31, 2020 (estimated)
Last update
May 9, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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