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

A Randomized, Controlled Phase II Study to Compare Preoperative Chemotherapies in Locally Advanced Gastric/Gastroesophageal Cancer

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)

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: S-1; Drug: Oxaliplatin; Drug: Trastuzumab; Drug: Docetaxel

Detailed Description

(HER2, human epidermal growth factor receptor-2) positive patients: After 4 cycles of SOX±Trastuzumab neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive 4 cycles of SOX±Trastuzumab adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team.

(HER2, human epidermal growth factor receptor-2,HER2) negative patients： After 4 cycles of DOS or SOX regimen as neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive then 4 cycles of DOS or SOX adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10000
      • Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Pathologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma;

2. The HER2 receptor protein status should be assessed using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH);

   • HER2 positive: IHC 3+ or IHC 2+/ FISH amplification.
   • HER2 negative: IHC 0, 1+ or IHC 2+/ FISH without amplification.
3. T3-4, any N stage, M0 of gastric or gastro-esophageal junction adenocarcinoma;
4. Chemotherapy and radiotherapy naïve.
5. Age ≥18 years;
6. ECOG(Eastern Cooperative Oncology Group ) 0-1;
7. Adequate hematological, hepatic and renal functions: absolute neutrophil count (ANC) ≥ 2.0 G/L, hemoglobin ≥ 90g/L, platelet ≥ 100 G/L; ALT and AST <1.5 times x upper limit of normal (ULN)；serum total bilirubin < 1.0 x ULN; serum creatinine < 1.0 x ULN;
8. Left ventricular ejection fraction>50%
9. Written informed consent.

Exclusion criteria:

1. Other pathology Type Other than adenocarcinoma, such as squamous cell carcinoma
2. History of allergies to drugs in the study
3. Intraperitoneal dissemination or distant metastasis
4. Digestive tract obstruction or uncontrollable recurrent bleeding ,clinical significant ascites
5. Dysphagia
6. Any cause of cirrhosis
7. Cardiac function NYHA(New York Heart Association) >I degrees
8. Previous myocardial infarction, unstable angina, stroke ,or uncontrollable Arrhythmia
9. Any surgical contraindication
10. Any chemotherapy or radiotherapy history
11. Any surgical resection history of gastric cancer
12. History of any other tumors except cured cutaneum carcinoma or carcinoma in situs of cervix
13. Any contraindication for chemotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Her2 Positive with SOX; Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.	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.; Other Names: Oxaliplatin; 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.; Other Names: S-1
Experimental: Her2 Positive with SOXT; Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), trastuzumab 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1, every 3 weeks.	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.; Other Names: Oxaliplatin; 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.; Other Names: S-1; 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.; Other Names: Oxaliplatin; S-1
Active Comparator: Her2 Negative with SOX; Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.	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.; Other Names: Oxaliplatin; 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.; Other Names: S-1
Experimental: Her2 Negative with DOS; Docetaxel 60 mg/m2, ivgtt, d1; Oxaliplatin 100 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) , 100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.	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.; Other Names: Oxaliplatin; 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.; Other Names: S-1; 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; Other Names: Oxaliplatin; S-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
major Pathological response rate	40 months

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Ping Ai Zhou, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 28, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 14, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• 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; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Docetaxel; Trastuzumab; Oxaliplatin
• Other Study ID Numbers: CH-GI-071

Plan for Individual participant data (IPD)

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