Study on Neoadjuvant Chemotherapy for Advanced Gastric Cancer

Phase 2

• Conditions: Advanced Gastric Carcinoma
• Interventions: Drug: paclitaxel liposome

• Registration Number: NCT02163291
• Lead Sponsor: Peking University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-06
• Study First Submitted: 2014-06-07
• Study First Submitted QC: 2014-06-11
• Last Update Submitted: 2014-06-11
• Study First Posted: 2014-06-13
• Last Update Posted: 2014-06-13
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
paclitaxel liposome	paclitaxel liposome	S-1 plus paclitaxel liposome

Primary Outcome Measures

Name	Time	Method
Pathological complete response rate	up to 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Object Response Rate	up to 24 weeks	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.
Disease Control Rate	up to 24 weeks	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.
Number of Participants with Adverse Eventss a Measure of Safety and Tolerability	up to 12 weeks	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.
R0 rate, surgical morbidity and mortality	2 weeks	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 .

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Haidian District, Beijing, China