Evaluate the Efficacy of Maintenance Treatment With Capecitabine Plus Apatinib in Advanced Gastric Cancer

Maintenance Treatment With Capecitabine Plus Apatinib vs. Apatinib and Observation After First-line XELOX/SOX Chemotherapy for Patients With Advanced Gastric Cancer: a Multicenter, Randomized, Controlled Trial

This is a multicenter, randomized, controlled trial to evaluate the efficacy and safety of Maintenance Treatment with Capecitabine plus Apatinib, Apatinib and Observation after First-line XELOX/SOX chemotherapy for Patients with Advanced Gastric Cancer

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Apatinib+Capecitabine; Drug: Apatinib

• Study Type: Interventional
• Enrollment (Anticipated): 288
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. aged 18-75；
2. had histologically confirmed unresectable and/or metastatic (primary or recurrent) adenocarcinoma of the stomach or gastroesophageal junction；
3. received 4-6 cycles of Xelox/SOX regimens as first-line chemotherapy and the response was not progression disease (PD);
4. ECOG 0-2；
5. Patients were tested for tumor HER2 status before treatment, and patients with HER2-negative disease；
6. presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines；
7. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;
8. Adequate organ function as defined below: Hematologic ANC ≥ 2*109/L, Platelets ≥ 100*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN
9. Receiving no form of chemotherapy, targeted therapy or other study medication;

Exclusion Criteria:

1. previous radiotherapy to the abdomen；
2. previous treatment for advanced disease (neoadjuvant chemotherapy was permitted if administered >6 months before enrollment)；
3. pregnant or lactating women or women of childbearing potential；
4. disease progression during the first-line chemotherapy;
5. active gastrointestinal bleeding, arterial thrombosis or cerebrovascular accident within 6 months before enrollment
6. previous treatment of apatinib and Ramucirumab

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Maintenance Treatment Group A; Maintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer	Drug: Apatinib+Capecitabine; Capecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d; Other Names: apatinib; capecitabine
NO_INTERVENTION: Observation Group; Observation after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
EXPERIMENTAL: Maintenance Treatment Group B; Maintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer	Drug: Apatinib; Apatinib 250mg po Qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	From date of randomization until the date of first documented death from any cause, assessed up to 36 months	36 months

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Chair: Xianglin Yuan, PhD,MD, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2018
• Primary Completion (ANTICIPATED): January 16, 2020
• Study Completion (ANTICIPATED): October 16, 2020

Study Registration Dates

• First Submitted: December 24, 2017
• First Submitted That Met QC Criteria: July 15, 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 15, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: advanced gastric cancer, apatinib, capecitabine, maintenance
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Protein Kinase Inhibitors; Capecitabine; Apatinib
• Other Study ID Numbers: TJCC006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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