Study on Neoadjuvant Chemotherapy for Advanced Gastric Cancer

Study Overview
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Brief Summary
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Gastric cancer is the second cause of cancer related death and China has the most gastric cancer patients in the world. Although systemic strategies, including adjuvant chemotherapy, postoperative chemoradiotherapy, perioperative chemotherapy, have evolved and showed benefits these years, the prognosis of advanced gastric cancer is still not satisfactory. Optimal regimens and optimal method administration is still being found. Neoadjuvant chemotherapy has many advantages, including downstaging the tumor, increasing R0 rate, early eradicating of micrometastasis. In previous trials, combination of paclitaxel and s-1 has showed safety and tolerance in recurrent or metastatic gastric cancer. Using liposome as a carrier, paclitaxel has a better histocompatibility and cellular affinity, resulting a improved stability and reduced toxicity. In this phase II trial, we are going to study the safety and feasibility of paclitaxel liposome plus s-1 as neoadjuvant chemotherapy.

Official Title
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Phase II Study of Paclitaxel Liposome Plus S-1 as Neoadjuvant Chemotherapy for Advanced Gastric Cancer

Conditions
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Advanced Gastric Carcinoma

Intervention / Treatment
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* Drug: paclitaxel liposome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed gastric cancer Disease at clinical stage of resectable or potentially resectable(T3-4, N0-3, M0) by CT and endoscopic ultrasonography (EUS) Karnofsky performance status(KPS） ≥ 70 No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy Life expectancy more than 3 months Adequate organ function as defined below:White Blood Cell Count （WBC） ≥ 3.0*10^9/l, Absolute Neutrophil Count （ANC） ≥ 1.5*10^9/l, Hemoglobin ≥ 100 g/l, Platelets ≥ 100*10^9/l, Total Bilirubin （TBIL） ≤ 1.5mg/dl, Aspartate Aminotransferase（AST） and Alanine Aminotransferase(ALT) ≤ 2.5×ULN, Alkaline pPosphatase( ALP) ≤ 2.5×ULN, Renal Serum Creatinine < 1.5mg/dl Adequate lung and heart function Exclusion Criteria: ≥ grade 2 neuropathy History of malignancy With uncontrolled central nervous system metastasis Concurrent disease or condition that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, acute infection, severe malnutrition, uncontrolled diabetes hypertension et al) Severely inadequate intake of water or diet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paclitaxel liposome<br>S-1 plus paclitaxel liposome | Drug: paclitaxel liposome<br>* S-1 40 mg/m2 bid d1-14 po and paclitaxel liposome 175mg/m2 d1 intravenously infusion for 3 hours, every 3 weeks. After 2 cycles' treatment, if clinical response is complete response（CR）,partial regression（PR） or stable disease（SD）, another 2 cycles is administered and operation is performed after the total 4 cycles. If response is progressive disease（PD）, chemotherapy is stopped and operation is performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response rate | Pathology is usually reported 1 week after operation.The result of Pathological complete response rate will be accessed after all of the 30 participants operated. | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Object Response Rate | Object Response Rate(ORR) is defined as the percentage of CR and PR among all of the participants under best overall outcome evaluation .Pathology is usually reported 1 week after operation.The result of Object Response Rate will be accessed after all of the 30 participants operated. | up to 24 weeks | 
| Disease Control Rate | Disease Control Rate(DC R) is defined as the percentage of CR+PR+SD among all of the participants under best overall outcome evaluation .Pathology is usually reported 1 week after operation.The result of Disease Control Rate will be accessed after all of the 30 participants operated. | up to 24 weeks | 
| Number of Participants with Adverse Eventss a Measure of Safety and Tolerability | Participants will be followed during all the s a Measure of Safety and Tolerability4 circles of chemotherapy ,an expected average of 12 weeks.Number of participants with Adverse Events will calculated as a Measure of Safety and Tolerability. | up to 12 weeks | 
| R0 rate, surgical morbidity and mortality | The results of R0 rate, surgical morbidity and mortality will be accessed after operation ,participants will be followed for the duration of hospital stay, an expected average of 2 weeks . | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced gastric cancer, neoadjuvant chemotherapy, safety, feasibility