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XELOX Combined With Apatinib as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma

Primary Purpose

Gastric Carcinoma

Status

Not yet recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Apatinib

About this trial

This is an interventional treatment trial for Gastric Carcinoma focused on measuring apatinib, Gastric Carcinoma, post-operative chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ECOG score is 0-1;
Radical gastrectomy (D2, R0) for gastric cancer has been performed (more than 16 lymph nodes have been detected);
Postoperative histology confirmed gastric adenocarcinoma；
The pathological stage of gastric cancer is ⅢA-ⅢC stage (8th AJCC TNM);
Subjects' baseline blood routine and biochemical indicators meet the following standards:
- ANC≥1.5×109/L;
- Hb≥90g/L;
- PLT≥100×109/L;
- TBIL≤1.5×ULN;
- ALT and AST≤2×ULN;
- Cr≤1.5×ULN
- INR：1.0～1.5; APTT is within the normal range
The electrocardiogram was basically normal before the first 4 weeks after admission, and there were no obvious clinical symptoms of heart disease;
Sign informed consent.

Exclusion Criteria:

Patients with severe hypertension and poor drug control;
Various factors that affect oral drugs such as (inability to swallow, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation ) ;
Patients with previous bradycardia or prolonged QT interval;
Patients with postoperative gastrointestinal fistula and wound rupture;
Known allergy to capecitabine or oxaliplatin, or metabolic disorder;
Patients receiving preoperative chemotherapy, radiotherapy or targeted therapy before;
Patients Using other experimental drugs at the same time or joining in other clinical trials.
Patients with severe liver diseases (such as liver cirrhosis), nephropathy, respiratory diseases or chronic systemic diseases such as uncontrollable diabetes and hypertension; Clinical symptoms of heart disease,such as congestive heart failure,coronary heart disease symptoms, arrhythmia, hypertension,that hard to control,or having myocardial infarction attack in six months or cardiac insufficiency.
Patients with peripheral nervous system disorder or with a history of significant psychiatric disorder and central nervous system disorder;

Sites / Locations

Anhui Provincial Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

treatment group

Control group

Arm Description

8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib'MTD(maximum tolerated dose)

8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w)

Outcomes

Primary Outcome Measures

Disease-free survival (DFS)

Disease-free survival (DFS) is defined as the time from the beginning of treatment to Disease recurrence or death due to Disease progression

Secondary Outcome Measures

Full Information

NCT ID

NCT03599778

First Posted

June 14, 2018

Last Updated

July 24, 2018

Sponsor

Anhui Provincial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03599778

Brief Title

XELOX Combined With Apatinib as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma

Official Title

A Phase I/II Clinical Study to Compare Postoperative Chemotherapy of Oxaliplatin With Capecitabine（XELOX）Combined With APATINIB as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma With D2 Dissection

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2018 (Anticipated)

Primary Completion Date

January 30, 2025 (Anticipated)

Study Completion Date

January 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anhui Provincial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To observe and evaluate the efficacy and safety of oxaliplatin with oapecitabine（XELOX）combined with apatinib as post-operative chemotherapy in locally advanced gastric adenocarcinoma with D2 dissection

Detailed Description

Stage 1 (phase I tolerance study) : 12 patients were enrolled in the dose-climbing study:According to the principle of dose-climbing test,todetermine the subjects' MTD, with the following three dose levels: Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 250 mg, qd x180d; ②. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 375 mg, qd x180d; ③. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 500 mg, qd x180d; Stage 2 (phase II exploratory study) : ①.Test group: subjects received 8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib maximum tolerated dose ②.Control group: Subjects received 8 cycles of XELOX regimen after surgery (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w). Eligible patients will receive 8 cycles of postoperative adjuvant therapy and will be followed up to death

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Carcinoma

Keywords

apatinib, Gastric Carcinoma, post-operative chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment group

Arm Type

Experimental

Arm Description

8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib'MTD(maximum tolerated dose)

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w)

Intervention Type

Drug

Intervention Name(s)

Apatinib

Other Intervention Name(s)

XELOX

Intervention Description

XELOX + apatinib's MTD

Primary Outcome Measure Information:

Title

Disease-free survival (DFS)

Description

Disease-free survival (DFS) is defined as the time from the beginning of treatment to Disease recurrence or death due to Disease progression

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ECOG score is 0-1; Radical gastrectomy (D2, R0) for gastric cancer has been performed (more than 16 lymph nodes have been detected); Postoperative histology confirmed gastric adenocarcinoma； The pathological stage of gastric cancer is ⅢA-ⅢC stage (8th AJCC TNM); Subjects' baseline blood routine and biochemical indicators meet the following standards: ANC≥1.5×109/L; Hb≥90g/L; PLT≥100×109/L; TBIL≤1.5×ULN; ALT and AST≤2×ULN; Cr≤1.5×ULN INR：1.0～1.5; APTT is within the normal range The electrocardiogram was basically normal before the first 4 weeks after admission, and there were no obvious clinical symptoms of heart disease; Sign informed consent. Exclusion Criteria: Patients with severe hypertension and poor drug control; Various factors that affect oral drugs such as (inability to swallow, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation ) ; Patients with previous bradycardia or prolonged QT interval; Patients with postoperative gastrointestinal fistula and wound rupture; Known allergy to capecitabine or oxaliplatin, or metabolic disorder; Patients receiving preoperative chemotherapy, radiotherapy or targeted therapy before; Patients Using other experimental drugs at the same time or joining in other clinical trials. Patients with severe liver diseases (such as liver cirrhosis), nephropathy, respiratory diseases or chronic systemic diseases such as uncontrollable diabetes and hypertension; Clinical symptoms of heart disease,such as congestive heart failure,coronary heart disease symptoms, arrhythmia, hypertension,that hard to control,or having myocardial infarction attack in six months or cardiac insufficiency. Patients with peripheral nervous system disorder or with a history of significant psychiatric disorder and central nervous system disorder;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xinyang He, master

Phone

13505518319

HXY2333@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xinyang He, master

Organizational Affiliation

Anhui Provincial Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anhui Provincial Cancer Hospital

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230000

Country

China

12. IPD Sharing Statement

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XELOX Combined With Apatinib as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma

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