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Optimizing the Strategy for Preoperative Chemotherapy in Locally Advanced Gastric/Gastroesophageal Cancer

NCT02725424 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-08-17

No results posted yet for this study

Summary

This is a randomized, phase II, open-label study. The purpose of this study is to determine the optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer according to their HER-2 expression status.

The primary endpoint of this study: major pathology response rate the second endpoints of this study: pathology complete response rate R0 resection rate Progression-free survival ( PFS) Disease -free survival (DFS) Overall survival(OS) Objective response rate(ORR) Adverse event(AE)

Conditions

Interventions

DRUG

S-1

Her-2 Positive patients with SOX Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA \<1.25m2) , 100mg(BSA ≥1.25m2, \<1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks.

DRUG

Trastuzumab

Her-2 positive patients with SOXT Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA \<1.25m2) , 100mg(BSA ≥1.25m2, \<1.5 m2), 120 mg(BSA≥ 1.5m2), Trastuzumab: 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1 Every 3 weeks.

DRUG

Oxaliplatin

Her-2 Positive patients with SOX Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA \<1.25m2) , 100mg(BSA ≥1.25m2, \<1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks.

DRUG

Docetaxel

Her-2 Negative patients with DOS Docetaxel： 60 mg/m2, iv, d1 Oxaliplatin：100 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA \<1.25m2) , 100mg(BSA ≥1.25m2, \<1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Ping Ai Zhou, MD · Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-12-31
Completion
2019-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02725424 on ClinicalTrials.gov