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Advanced Gastric CarcinomaPhase 2NCT02163291

Study on Neoadjuvant Chemotherapy for Advanced Gastric Cancer

A Phase 2 study testing paclitaxel liposome in people with Advanced Gastric Carcinoma, run by Peking University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Gastric Carcinoma
What is being tested?
paclitaxel liposome
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Dec 2013to Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • ≥ 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

Trial locations and contacts

1 site in 1 country.

Jiafu Ji, M.D. contact

jiafuj@hotmail.com

China1 site

  • Peking University Cancer Hospital

    Haidian District, Beijing, 100142

    Ziyu Li, M.D., ligregory369@hotmail.com

    Zhaodong Xing, M.D., xingzhaodong2011@sina.com

Other trials in China

About this study

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

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.

Being tested
paclitaxel liposome
Keywords
advanced gastric cancer, neoadjuvant chemotherapy, safety, feasibility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • paclitaxel liposomeDrug

    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.

Study groups in NCT02163291
Study groupRoleWhat they receive
paclitaxel liposomeExperimentalS-1 plus paclitaxel liposome
Receives: Drug: paclitaxel liposome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 24 weeks

Secondary outcomes (4)

  1. 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.

    Measured: up to 24 weeks

  2. 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.

    Measured: up to 24 weeks

  3. 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.

    Measured: up to 12 weeks

  4. 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 .

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2014 (estimated)
  4. Study completionDec 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02163291
Sponsor's protocol ID
LPS-01-2013
Status last verified
Jun 2014
First submitted
7 Jun 2014
Last updated
13 Jun 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20207133

  • 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.

    PubMed 19019625

  • 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.

    PubMed 24453274

  • 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.

    PubMed 23810466

  • 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.

    PubMed 18813927

  • 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.

    PubMed 18317763

  • 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.

    PubMed 22617130

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing paclitaxel liposome in people with Advanced Gastric Carcinoma, run by Peking University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jiafu Ji, M.D. (jiafuj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02163291, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014.

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