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Gastric CancerNCT06490055

Predicting the Efficacy in Advanced Gastric Cancer.

An observational study of Gastric Cancer and Chemotherapy Effect, run by City of Hope Medical Center at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

With advances in chemotherapy for gastric cancer, it is important to identify patients who will respond effectively to specific therapies. This longitudinal study aimed to establish a liquid-biopsy assay that can predict response to ramucirumab plus paclitaxel therapy in patients with advanced gastric cancer. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Gastric Cancer, Chemotherapy Effect, Paclitaxel
What is being tested?
Paclitaxel
How many people
162 participants
Where
2 sitesin 2 countries
Study dates
1 Oct 2018to 1 Jul 2025
How long will I take part?
2 Years
Phase
Observational
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients need second-line chemotherapy with unresectable or recurrent Gastric cancer.

Who may be able to join

  • unresectable or recurrent GC histologically confirmed to be primary adenocarcinoma of the stomach.
  • age over 20 years.
  • Eastern Cooperative Oncology Group performance status score of 0-2.
  • written informed consent following full study information is provided to the patient.
  • progression or intolerance for first-line chemotherapy comprising fluorinated pyrimidine and platinum anticancer drugs (cisplatin or oxaliplatin) for advanced GC.
  • presence of evaluable lesions as confirmed using a computed tomography (CT) or magnetic resonance imaging.

Who cannot join

  • Patients with a life expectancy of shorter than 3 months
  • Patients with severe complications (angina pectoris, myocardial infarction, or arrhythmia) or uncontrollable diabetes mellitus, blood hypertension, or bleeding tendency.
  • Patients with a history of serious allergic reactions or serious drug allergy.
  • Patients with a clinically relevant mental disorder that prohibits response to questionnaires.
  • Patients for whom the attending physician considered that enrollment in the study is inappropriate.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site
  • Department of Molecular Diagnostics and Experimental Therapeutics

    Monrovia, California, 91016

Other trials in United States

Japan1 site
  • Kawasaki Medical University

    Kurashiki, Okayama-ken, 7010192

Other trials in Japan

About this study

Official title: Predicting the Efficacy of Paclitaxel Plus Ramucirumab in Advanced Gastric Cancer.

With advances in chemotherapy for gastric cancer, it is important to identify patients who will respond effectively to specific therapies. This longitudinal study aimed to establish a liquid-biopsy assay that can predict response to ramucirumab plus paclitaxel therapy in patients with advanced gastric cancer.

Read the detailed description

The combination of paclitaxel and ramucirumab is a potent standard second-line therapy for patients with advanced gastric cancer, but approximately 30% of patients do not respond to treatment. Failure to respond to second-line therapy can lead not only to disease progression, but also to deterioration of the patient's health and loss of the opportunity to receive other treatments that originally had the potential to be curative. This study aims to predict the efficacy of second-line treatment (paclitaxel plus ramucirumab) in patients with gastric cancer using liquid biopsies (small RNA). Prediction using pre-treatment blood may allow patients who do not respond to treatment to choose other treatment options. This study aims to establish a tool that will enable noninvasive pre-treatment selection, which could lead to personalized treatment.

Being tested
Paclitaxel
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • PaclitaxelDrug

    Also called Ramucirumab

    Gastric cancer second-line Chemotherapy (paclitaxel plus ramucirumab)

Study groups in NCT06490055
Study groupRoleWhat they receive
Gastric cancer chemotherapy responders received second-line chemotherapyResponders according to the response evaluation criteria in solid tumors (RECIST). A panel of microRNA, whose expression level is tested exosomal microRNA from blood sample before second-line chemotherapy with reverse transcriptase quantitative polymerase chain reaction (RT-qPCR)
Receives: Drug: Paclitaxel
Gastric cancer chemotherapy non-responders received second-line chemotherapyNon-responders according to the response evaluation criteria in solid tumors (RECIST). A panel of microRNA, whose expression level is tested exosomal microRNA from blood sample before second-line chemotherapy with reverse transcriptase quantitative polymerase chain reaction (RT-qPCR)
Receives: Drug: Paclitaxel

What is being measured

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

  1. Chemotherapy response

    Follows by response valuation criteria in solid tumors (RECIST) evaluation. Partial response (PR) and Stable disease (SD) are defined as treatment effective, while Progressive disease (PD) is defined as no treatment effective.

    Measured: 2 years

Timeline

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

  1. First posted8 Jul 2024
  2. Study start1 Oct 2018
  3. Primary completion18 Feb 2025
  4. Study completion1 Jul 2025

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
162 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06490055
Sponsor's protocol ID
23228/SLCGC
Status last verified
Jul 2025
First submitted
21 Jun 2024
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338
  • Ajani JA, D'Amico TA, Bentrem DJ, Chao J, Cooke D, Corvera C, Das P, Enzinger PC, Enzler T, Fanta P, Farjah F, Gerdes H, Gibson MK, Hochwald S, Hofstetter WL, Ilson DH, Keswani RN, Kim S, Kleinberg LR, Klempner SJ, Lacy J, Ly QP, Matkowskyj KA, McNamara M, Mulcahy MF, Outlaw D, Park H, Perry KA, Pimiento J, Poultsides GA, Reznik S, Roses RE, Strong VE, Su S, Wang HL, Wiesner G, Willett CG, Yakoub D, Yoon H, McMillian N, Pluchino LA. Gastric Cancer, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 Feb;20(2):167-192. doi: 10.6004/jnccn.2022.0008.

    PubMed 35130500
  • Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, Dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-39. doi: 10.1016/S0140-6736(13)61719-5. Epub 2013 Oct 3.

    PubMed 24094768
  • Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.

    PubMed 25240821
  • Xu RH, Zhang Y, Pan H, Feng J, Zhang T, Liu T, Qin Y, Qin S, Yin X, Liu B, Ba Y, Yang N, Voon PJ, Tanasanvimon S, Zhou C, Zhang WL, Shen L. Efficacy and safety of weekly paclitaxel with or without ramucirumab as second-line therapy for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma (RAINBOW-Asia): a randomised, multicentre, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Dec;6(12):1015-1024. doi: 10.1016/S2468-1253(21)00313-7. Epub 2021 Oct 7.

    PubMed 34626550
  • Van Cutsem E, Muro K, Cunningham D, Bodoky G, Sobrero A, Cascinu S, Ajani J, Oh SC, Al-Batran SE, Wainberg ZA, Wijayawardana SR, Melemed S, Ferry D, Hozak RR, Ohtsu A; RAINBOW Investigators. Biomarker analyses of second-line ramucirumab in patients with advanced gastric cancer from RAINBOW, a global, randomized, double-blind, phase 3 study. Eur J Cancer. 2020 Mar;127:150-157. doi: 10.1016/j.ejca.2019.10.026. Epub 2020 Jan 31.

    PubMed 32014812
  • Natsume M, Shimura T, Iwasaki H, Okuda Y, Kitagawa M, Okamoto Y, Hayashi K, Kataoka H. Placental growth factor is a predictive biomarker for ramucirumab treatment in advanced gastric cancer. Cancer Chemother Pharmacol. 2019 Jun;83(6):1037-1046. doi: 10.1007/s00280-019-03817-2. Epub 2019 Mar 21.

    PubMed 30899983
  • Aprile G, Ongaro E, Del Re M, Lutrino SE, Bonotto M, Ferrari L, Rihawi K, Cardellino GG, Pella N, Danesi R, Fasola G. Angiogenic inhibitors in gastric cancers and gastroesophageal junction carcinomas: A critical insight. Crit Rev Oncol Hematol. 2015 Aug;95(2):165-78. doi: 10.1016/j.critrevonc.2015.02.009. Epub 2015 Mar 5.

    PubMed 25800976
  • Shigeyasu K, Toden S, Zumwalt TJ, Okugawa Y, Goel A. Emerging Role of MicroRNAs as Liquid Biopsy Biomarkers in Gastrointestinal Cancers. Clin Cancer Res. 2017 May 15;23(10):2391-2399. doi: 10.1158/1078-0432.CCR-16-1676. Epub 2017 Jan 31.

    PubMed 28143873
  • Yu W, Hurley J, Roberts D, Chakrabortty SK, Enderle D, Noerholm M, Breakefield XO, Skog JK. Exosome-based liquid biopsies in cancer: opportunities and challenges. Ann Oncol. 2021 Apr;32(4):466-477. doi: 10.1016/j.annonc.2021.01.074. Epub 2021 Feb 4.

    PubMed 33548389
  • Tang XH, Guo T, Gao XY, Wu XL, Xing XF, Ji JF, Li ZY. Exosome-derived noncoding RNAs in gastric cancer: functions and clinical applications. Mol Cancer. 2021 Jul 30;20(1):99. doi: 10.1186/s12943-021-01396-6.

    PubMed 34330299
  • Huang T, Song C, Zheng L, Xia L, Li Y, Zhou Y. The roles of extracellular vesicles in gastric cancer development, microenvironment, anti-cancer drug resistance, and therapy. Mol Cancer. 2019 Mar 30;18(1):62. doi: 10.1186/s12943-019-0967-5.

    PubMed 30925929
  • Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977.

    PubMed 32029601
  • Tanioka H, Nagasaka T, Uno F, Inoue M, Okita H, Katata Y, Kanzaki H, Kuramochi H, Satake H, Shindo Y, Doi A, Nasu J, Yamashita H, Yamaguchi Y. The relationship between peripheral neuropathy and efficacy in second-line chemotherapy for unresectable advanced gastric cancer: a prospective observational multicenter study protocol (IVY). BMC Cancer. 2019 Oct 11;19(1):941. doi: 10.1186/s12885-019-6163-6.

    PubMed 31604467
  • Shitara K, Takashima A, Fujitani K, Koeda K, Hara H, Nakayama N, Hironaka S, Nishikawa K, Makari Y, Amagai K, Ueda S, Yoshida K, Shimodaira H, Nishina T, Tsuda M, Kurokawa Y, Tamura T, Sasaki Y, Morita S, Koizumi W. Nab-paclitaxel versus solvent-based paclitaxel in patients with previously treated advanced gastric cancer (ABSOLUTE): an open-label, randomised, non-inferiority, phase 3 trial. Lancet Gastroenterol Hepatol. 2017 Apr;2(4):277-287. doi: 10.1016/S2468-1253(16)30219-9. Epub 2017 Jan 19.

    PubMed 28404157

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer and Chemotherapy Effect, run by City of Hope Medical Center at 2 sites in 2 countries.

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 6 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: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Japan. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chemotherapy response (time frame: 2 years). 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 NCT06490055, which also lists 30 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 18 Jul 2025.

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