Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel liposome | Experimental | S-1 plus paclitaxel liposome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel liposome | Drug | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiafu Ji, M.D. | Contact | jiafuj@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiafu Ji, M.D. | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Haidian District, Beijing | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20207133 | Background | Wang X, Zhou J, Wang Y, Zhu Z, Lu Y, Wei Y, Chen L. A phase I clinical and pharmacokinetic study of paclitaxel liposome infused in non-small cell lung cancer patients with malignant pleural effusions. Eur J Cancer. 2010 May;46(8):1474-80. doi: 10.1016/j.ejca.2010.02.002. Epub 2010 Mar 6. | |
| 19019625 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| Zhang Q, Huang XE, Gao LL. A clinical study on the premedication of paclitaxel liposome in the treatment of solid tumors. Biomed Pharmacother. 2009 Sep;63(8):603-7. doi: 10.1016/j.biopha.2008.10.001. Epub 2008 Oct 31. |
| 24453274 | Background | Chen L, Chen Q, Zhuang Z, Zhang Y, Tao J, Shen L, Shen X, Chen Z, Wang J, Zhu M, Wang H. Effect of the weekly administration of liposome-Paclitaxel combined with s-1 on advanced gastric cancer. Jpn J Clin Oncol. 2014 Mar;44(3):208-13. doi: 10.1093/jjco/hyt212. Epub 2014 Jan 22. |
| 23810466 | Background | Huang D, Ba Y, Xiong J, Xu N, Yan Z, Zhuang Z, Yu Z, Wan H, Zhang Y, Deng T, Zheng R, Guo Z, Hu C, Wang M, Yu Z, Yao Y, Meng J. A multicentre randomised trial comparing weekly paclitaxel + S-1 with weekly paclitaxel + 5-fluorouracil for patients with advanced gastric cancer. Eur J Cancer. 2013 Sep;49(14):2995-3002. doi: 10.1016/j.ejca.2013.05.021. Epub 2013 Jun 27. |
| 18813927 | Background | Lee JJ, Kim SY, Chung HC, Lee KH, Song HS, Kang WK, Hong YS, Choi IS, Lee YY, Woo IS, Choi JH. A multi-center phase II study of S-1 plus paclitaxel as first-line therapy for patients with advanced or recurrent unresectable gastric cancer. Cancer Chemother Pharmacol. 2009 May;63(6):1083-90. doi: 10.1007/s00280-008-0818-3. Epub 2008 Sep 24. |
| 18317763 | Background | Nakajo A, Hokita S, Ishigami S, Miyazono F, Etoh T, Hamanoue M, Maenohara S, Iwashita T, Komatsu H, Satoh K, Aridome K, Morita S, Natsugoe S, Takiuchi H, Nakano S, Maehara Y, Sakamoto J, Aikou T; Kyushu Taxol TS-1 Study Group. A multicenter phase II study of biweekly paclitaxel and S-1 combination chemotherapy for unresectable or recurrent gastric cancer. Cancer Chemother Pharmacol. 2008 Nov;62(6):1103-9. doi: 10.1007/s00280-008-0693-y. Epub 2008 Mar 4. |
| 22617130 | Background | Mochiki E, Ogata K, Ohno T, Toyomasu Y, Haga N, Fukai Y, Aihara R, Ando H, Uchida N, Asao T, Kuwano H; North Kanto Gastric Cancer Study Group. Phase II multi-institutional prospective randomised trial comparing S-1+paclitaxel with S-1+cisplatin in patients with unresectable and/or recurrent advanced gastric cancer. Br J Cancer. 2012 Jun 26;107(1):31-6. doi: 10.1038/bjc.2012.222. Epub 2012 May 22. |