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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Carcinoma
• Intervention / Treatment: Drug: Apatinib

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

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xinyang He, master; Phone Number: 13505518319; Email: HXY2333@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Anhui Provincial Cancer Hospital

Participation Criteria

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. ECOG score is 0-1;
2. Radical gastrectomy (D2, R0) for gastric cancer has been performed (more than 16 lymph nodes have been detected);
3. Postoperative histology confirmed gastric adenocarcinoma；
4. The pathological stage of gastric cancer is ⅢA-ⅢC stage (8th AJCC TNM);

5. 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
6. The electrocardiogram was basically normal before the first 4 weeks after admission, and there were no obvious clinical symptoms of heart disease;
7. Sign informed consent.

Exclusion Criteria:

1. Patients with severe hypertension and poor drug control;
2. Various factors that affect oral drugs such as (inability to swallow, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation ) ;
3. Patients with previous bradycardia or prolonged QT interval;
4. Patients with postoperative gastrointestinal fistula and wound rupture;
5. Known allergy to capecitabine or oxaliplatin, or metabolic disorder;
6. Patients receiving preoperative chemotherapy, radiotherapy or targeted therapy before;
7. Patients Using other experimental drugs at the same time or joining in other clinical trials.
8. 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.
9. Patients with peripheral nervous system disorder or with a history of significant psychiatric disorder and central nervous system disorder;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: treatment group; 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)	Drug: Apatinib; XELOX + apatinib's MTD; Other Names: XELOX
ACTIVE_COMPARATOR: Control group; 8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w)	Drug: Apatinib; XELOX + apatinib's MTD; Other Names: XELOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Investigators: Principal Investigator: Xinyang He, master, Anhui Provincial Cancer Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2018
• Primary Completion (ANTICIPATED): January 30, 2025
• Study Completion (ANTICIPATED): January 30, 2025

Study Registration Dates

• First Submitted: June 14, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: apatinib; Gastric Carcinoma; post-operative chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: AHTH-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No