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Gastrointestinal Diseases

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Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Cisplatin

S-1：40\~60mg bid，d1\~14 q3W cisplatin：60mg/m2，iv drip ，d1,q3W Number of Cycles: until progression or unacceptable toxicity develops.

S-1：40\~60mg bid，d1\~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W Number of Cycles: until progression or unacceptable toxicity develops.

oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W

ruihua xu, Professor

The purpose of this study is to evaluate the effectiveness and safety of S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients.

The primary endpoint is Overall survival time (OS).Secondary endpoints are overall response rate (ORR), time to treatment failure (TTF),progression free survival (PFS)and the adverse reactions(AE) of the two groups .

Study design:

This is a prospective randomized control study.

Sample size:

Sample size considerations were based on the survival end point. The improvement in median survival from 10 months in the S-1+cisplatin arm to 13 months in the S-1+oxaliplatin arm was considered clinically relevant in this patient population. A total of 576 patients were required for a two-tailed log-rank test at the 5% significance and at least 80% power. The planned enrolled time was 48 months and 1 year of follow up, and a drop-out rate of 5%.

S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients

A Randomized, Open, Multi-center, Phase III Study of S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients

OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 12 weeks till death or lost

The primary endpoint is objective response rate,which equals CR+PR.

The duration is from the randomized time to treatment termination due to any reason. The reasons may include disease progression, treatment toxicity, patient selection or death.

The duration is from the randomized time to disease progression or death due to any reason.

Taiho Pharmaceutical Co., Ltd.

Sun Yat-sen University

vice president of SunYat-sen University Cancer Center,head of medical oncology department

Capecitabine

Apatinib

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

In this arm, patients will receive a daily oral treatment with Apatinib 500mg.

In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks.

In this arm, no additional treatment will be given, and patients will be followed up at regular time

Capecitabine: 1000mg/m2 bid po, d1-14, q3w

The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.

Up to now, whether maintenance therapy after first line treatment can bring survival benefits to patients with advanced gastric cancer is unknown, and let alone which drug is most suitable. Our study is designed to prove whether the maintenance treatment of Apatinib or Capecitabine are better than observation after fluorouracil/platinum based first-line chemotherapy in advanced gastric cancer

The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer

A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer

we will use EORTC QLQ-C30 to evaluate QoL.

we will use CTC AE4.0 to evaluate adverse events.

PFS is calculated from the time of randmization to disease progression or death whichever happen first

OS is calculated from the time of randmization to death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients	NCT01824459	Gastric Cancer	S-1 Oxaliplatin Cisplatin	18 Years - 75 Years	Sun Yat-sen University
The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer	NCT03889626	Stomach Neoplas... Gastrointestina... Stomach Disease... Digestive Syste... Capecitabine Apatinib Neoplasms Molecular Mecha...	Apatinib Capecitabine	18 Years - 90 Years	Fudan University
S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients	NCT01824459	Gastric Cancer	S-1 Oxaliplatin Cisplatin	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for advance gastric cancer