The Study of Conversion Surgery for Apatinib in Combination With SOX for Patients With Unresectable Gastric Cancer

September 25, 2017 updated by: Lin Chen, Chinese PLA General Hospital

The Exploratory Study of Conversion Surgery for Apatinib in Combination With Oxaliplatin/S-1(SOX) for Patients With Unresectable Gastric Cancer

This is a Prospective，Single-center，Single-arm，Open-label exploratory clinical trial evaluating the efficacy and safety of Conversion Surgery for Apatinib plus SOX for patients with unresectable gastric cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is the second most common cause of cancer-related deaths worldwide, and surgical resection during the early stage has improved treatment outcomes.However, many patients are diagnosed with unresectable advanced or metastatic stage disease losing the radical surgery opportunity. Systemic chemotherapy is the leading treatment that prolongs survival times for such patients.

Approximate 20 patients with unresectable gastric cancer will be enrolled in this study,the investigators will evaluate the efficacy and security of Apatinib + SOX(oxaliplatin+S-1) for unresectable gastric cancer.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100853
        • Recruiting
        • The Chinese PLA General Hospital
        • Contact:
          • Lin Chen, Master
          • Phone Number: 13801290395

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically proved gastric adenocarcinoma;
  2. At least a unresectable factor before operation via CT, MRI, or PET-CT: difficult resection of locally advanced gastric cancer(T4b); hepatic metastasis (H1; at most five lesions, total diameter ≤8 cm); Peritoneal metastasis(CY1, P1) ;
  3. Definitely diagnosed as unresectable gastric cancer via exploratory laparoscopy or laparotomy;
  4. ECOG performance status 0-2;
  5. Age 18-70 years old, Life expectancy estimated than 3 months;

  6. For results of blood routine test and biochemical tests:

    1. Hgb ≥ 80g/L,
    2. WBC ≥ 4000/mm3,
    3. ANC ≥ 1.5×109/L,
    4. platelets ≥ 80×109/L
    5. ALT and AST ≤ 2.5 x upper normal limit (UNL), and ≤ 5 x UNL（Hematogenous metastases）,
    6. Serum Total bilirubin ≤ 1.5 X UNL,
    7. Serum Creatine ≤ 1.5 x UNL ；
  7. Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease;
  8. Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver);
  9. informed consent.

Exclusion Criteria:

  1. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than Class I; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction; Patients with positive urinary protein;
  2. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
  3. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;
  4. Contraindications include allergy to apatinib and/or its accessories, active bleeding, intestinal perforation, intestinal obstruction, within 30 days after surgery, drugs with poor-controlled hypertension, Class Ⅲ-Ⅳ cardiac dysfunction （NYHA standard）, severe hepatic and renal dysfunction（level 4）if apatinib use is considered;
  5. Abnormal Coagulation (INR>1.5, APTT>1.5 UNL), with tendency of bleed;
  6. Pregnant or lactating women;
  7. Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
  8. Treatment with prior radiotherapy, chemotherapy, Targeted therapy or immunotherapy;
  9. Other conditions regimented at investigators' discretion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apatinib plus Oxaliplatin/S-1

  1. Apatinib :

    A starting dose of apatinib was administered 500 mg daily on days 1 through 21 of each 3-week cycle.

  2. Oxaliplatin:130 mg/m2，d1，ivgtt，in a 21 day cycle.
  3. S-1:40mg，bid，d1-14，po，in a 21 day cycle.
Drug: Apatinib
Apatinib :A starting dose of apatinib was administered 500 mg daily
Other Names:
  • Apatinib mesylate tablets
Drug: Oxaliplatin
Oxaliplatin:130 mg/m2，d1，ivgtt，in a 21 day cycle
Drug: S-1
S-1:40mg，bid，d1-14，po，in a 21 day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reaction rate
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: 6 months
6 months
Overall Survival
Time Frame: 3 years
3 years
Objective Response Rate
Time Frame: an expected average of 6 weeks
an expected average of 6 weeks
Disease-free survival
Time Frame: an expected average of 6 weeks
an expected average of 6 weeks
Progression-Free Survival
Time Frame: an expected average of 6 weeks
an expected average of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Lin Chen, The Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Actual)

September 27, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ahead-BG301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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