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Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer

Primary Purpose

Apatinib Combined, SOX, Neoadjuvant Therapy

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ApatinibMesylateTablets
Sponsored by
Chang-Ming Huang, Prof.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apatinib Combined

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age from 18 to 75 years
  2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  3. cT2-4N+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  4. No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
  5. Performance status of 0 or 2 on Eastern Cooperative Oncology Group scale (ECOG)
  6. Without previous surgical, chemotherapy,radiotherapy, immunotherapy, or targeted therapy for gastric cancer.
  7. Estimate life is equal or greater than 3 months
  8. No serious heart, lung, liver dysfunction;no Jaundice and obstruction of the digestive tract; no acute infection

  9. The main organ function is normal,and meet the following criteria:

    • blood routine examination( No blood transfusion within 14 days)

      1. HB≥100g/L，
      2. WBC≥3.5×109/L
      3. ANC≥1.5×109/L，
      4. PLT≥100×109/L；

    • blood biochemical examination

      1. BIL <1.5 Upper Limit Of Normal（ULN），
      2. ALT and AST<2.5ULN，GPT≤1.5×ULT；
      3. Cr≤1ULN，creatinine clearance>60ml/min（Cockcroft-Gault formula）
  10. Written informed consent

Exclusion Criteria:

  1. Pregnant and lactating women
  2. Suffering from severe mental disorder
  3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
  4. History of previous chemotherapy or radiotherapy therapy
  5. History of other malignant disease within the past 5 years
  6. History of previous neoadjuvant chemotherapy or radiotherapy
  7. History of unstable angina or myocardial infarction within the past 6 months
  8. History of cerebrovascular accident within the past 6 months
  9. History of continuous systematic administration of corticosteroids within 1 month
  10. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  11. 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).
  12. Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content>1.0g)
  13. There are several factors that affect oral medicine,such as unable to swallow, uncontrollable nausea and vomitin, or chronic diarrhea and intestinal obstruction
  14. Drug allergy to experimental medicine

Sites / Locations

  • Fujian Medical University Union Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib Combined With SOX

Arm Description

In 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
overall response rate
according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1
5-year overall survival rate
5-year disease free survival rate
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.
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
30 days mortality rates
Defined as the event observed within 30 days after surgery.
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.

Full Information

First Posted
June 18, 2017
Last Updated
February 4, 2020
Sponsor
Chang-Ming Huang, Prof.
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1. Study Identification

Unique Protocol Identification Number
NCT03192735
Brief Title
Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 11, 2019 (Actual)
Study Completion Date
December 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chang-Ming Huang, Prof.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apatinib Combined, SOX, Neoadjuvant Therapy, Locally Advanced Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apatinib Combined With SOX
Arm Type
Experimental
Arm Description
In 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.
Intervention Type
Drug
Intervention Name(s)
ApatinibMesylateTablets
Other Intervention Name(s)
Oxaliplatin for Injection, Gimeracil and Oteracil Porassium Capsules
Intervention Description
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.
Primary Outcome Measure Information:
Title
Radical surgical resection rate
Description
Radical surgical resection rate is defined as the rate of R0 resection
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Pathological response rate
Description
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.
Time Frame
30 days
Title
overall response rate
Description
according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1
Time Frame
30 days
Title
5-year overall survival rate
Time Frame
60 months
Title
5-year disease free survival rate
Time Frame
60months
Title
overall postoperative morbidity rates
Description
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
Time Frame
30 days
Title
Duration of postoperative hospital stay
Description
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
30 days mortality rates
Description
Defined as the event observed within 30 days after surgery.
Time Frame
30 days
Title
adverse event
Description
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.
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 Exclusion Criteria: 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 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
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34241629
Citation
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.
Results Reference
derived

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Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer

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