Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Docetaxel

Oxaliplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

docetaxel plus oxaliplatin and capecitabine

docetaxel 50mg/㎡ ivgtt. d1+oxaliplatin 100mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d

oxaliplatin 130mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d

oxaliplatin plus capecitabine

Ning Li, PhD

Ning LI, PhD

Suxia Luo, PhD

This study was a prospective, randomized, controlled phase III clinical study to evaluate the efficacy and safety of docetaxel plus oxaliplatin and capecitabine versus oxaliplatin plus capecitabine in the treatment of gastric or gastroesophageal junction adenocarcinoma with postoperative pathological stage IIIB and IIIC.

In 2019, CSCO guidelines grade I recommend gastric or gastroesophageal junction adenocarcinoma patients, after D2 R0 resection, whose postoperative pathological stage was III treated with XELOX as an adjuvant chemotherapy. However, some retrospective clinical studies in China suggest that the 3-year DFS rate of XELOX program as an adjuvant postoperative chemotherapy program is still low, and the risk of recurrence is higher for patients with postoperative pathological stage IIIB/IIIC.In recent years, the success of the JACCRO GC-07 trial has provided evidence for the value of Taxoids in postoperative adjuvant therapy of gastric cancer. In the FLOT4 trial, the FLOT improved the DFS rate by 3 years compared with the ECF/ECX. At present, there is no clinical study data to prove whether the combined three-drug regimen can further reduce the risk of postoperative recurrence and improve the treatment effect compared with oxaliplatin combined capecitabine two-drug regimen for patients with high postoperative recurrence risk (patients with postoperative pathological stage IIIB/IIIC). Therefore, the investigators carried out this trial.

A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer

The Efficacy and Safety of Postoperative Chemotherapy With Docetaxel Plus Oxaliplatin and Capecitabine Versus Oxaliplatin Plus Capecitabine for Postoperative Pathological Stage IIIB/IIIC Gastric Adenocarcinoma: a Randomised, Phase 3 Trial

From the date of randomization until the date of the first recorded disease recurrence, metastasis or death from any cause, whichever came first.

From the date of randomization until the date of the first recorded death from any cause. For subjects lost to follow-up prior to death, the last follow-up time is usually calculated as the time of death.

Adverse reaction will be assessed by NCI CT CAE v5.0.

Quality of life will be assessed using The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Cancer (QLQ-C30) and the site-specific module for gastric cancer (QLQ-STO22) . These tables will be usde together to assessed the quality of life of the patients. The higher the score, the worse the quality of life.

LiNing

Chief Physician

Symptoms and General Pathology

Neoplasm Metastasis

Liver Neoplasms

Neoplastic Processes

Liver Diseases

Hematinics

Trastuzumab

Liver Extracts

Antineoplastic Agents, Immunological

drug: Oxaliplatin;Capecitabine;Herceptin A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Herceptin 8mg/kg D1 q3wk for the first time,after Herceptin 6mg/kg D1 q3wk.Evaluation for every two cycles.Each of preoperative and postoperative chemotherapy was 3 cycles.

To explore the effect of herceptin with chemotherapy for potentially resectable HER-2 positive gastric cancer with liver metastasis

A cycle: Oxaliplatin 130 mg/m2 D1 q3wk.E Capecitabine 2000mg/m2 D1-D14 q3wk、valuation for every two cycles.

Oxaliplatin plus Capecitabine

Herceptin 8mg/kg D1 q3wk for the first time,after Herceptin 6mg/kg D1 q3wk.Evaluation for every two cycles.Each of preoperative and postoperative chemotherapy was 3 cycles.

Herceptin

Qun Zhao, Doctor

Qun Zhao, Dortor

Stage I：preoperative therapy

* Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage II: Perioperative therapy
* Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant Capecitabine plus oxaliplatin alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis;

The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with herceptin to improves R0 resection rate and survival among patients with potentially resectable HER-2 positive gastric cancer with liver metastasis.

Perioperative Chemotherapy With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis

Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Herceptin in Patients With Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis

Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer	NCT04351867	Stomach Neoplas...	docetaxel plus ... oxaliplatin plu...	18 Years - 75 Years	Henan Cancer Hospital
Perioperative Chemotherapy With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis	NCT02380131	HER-2 Positive ... Liver Metastasi...	Oxaliplatin plu... Herceptin	18 Years - 75 Years	Hebei Medical University
A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer	NCT04351867	Stomach Neoplas...	docetaxel plus ... oxaliplatin plu...	18 Years - 75 Years	Henan Cancer Hospital

Spots Global Cancer Trial Database for oxaliplatin plus capecitabine