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Advanced Gastric CarcinomaNCT05351398

The Clinical Efficacy of Drug Sensitive Neoadjuvant Chemotherapy Based on Organoid Versus Traditional Neoadjuvant Chemotherapy in Advanced Gastric Cancer

An observational study of Advanced Gastric Carcinoma, run by Shanghai Minimally Invasive Surgery Center 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Neoadjuvant chemotherapy has become the mainstream recommended treatment for advanced gastric cancer. However, due to the heterogeneity of gastric cancer, part of some patients fail to benefit from the treatment. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Gastric Carcinoma
What is being tested?
PDO group and Traditional group
How many people
54 participants
Where
1 siteChina
Study dates
Apr 2022to Dec 2023
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with advanced gastric cancer whose tumor is located in the stomach and need neoadjuvant therapy before radical surgery.

Who may be able to join

  • Age between 18 and 80 years
  • A biopsy proven histological diagnosis of gastric adenocarcinoma or high-grade intraepithelial neoplasia
  • Tumor located at stomach
  • Chest/abdomen/pelvis CT scans or gastric cancer staging CT scan evaluate the clinical stage of tumor as stage III:
  • preoperative staging cT3-4N1-2 B. excluding distant organ metastasis (M0)
  • Eastern Cooperative Oncology Group (ECOG) score ≤1
  • Willing to participate and informed consent signed

Who cannot join

  • Pregnant or lactating women
  • Synchronous or heterochronic malignant carcinomas
  • History of malignant carcinomas
  • Clinical evidence of metastasis
  • Abnormal heart, lung, liver, kidney, hematopoietic function and bone marrow reserve function, unable to tolerate surgical treatment and chemotherapy
  • Mental illness or other serious cardiovascular disease
  • Emergency procedure

Trial locations and contacts

1 site in 1 country.

Jin Sun, PhD contact

+86-21-64370045

sj11788@rjh.com.cn

China1 site

  • Shanghai Ruijin Hospttal

    Shanghai, Sahnghai, 200000

    Yanye Yang, Bachelor, +86-13636419858, young0503@163.com

Other trials in China

About this study

Official title: The Clinical Efficacy of Patient-derived Organoid-based Drug Sensitive Neoadjuvant Chemotherapy Versus Traditional Neoadjuvant Chemotherapy in Advanced Gastric Cancer: a Prospective Multi-center Randomized Controlled Study

Neoadjuvant chemotherapy has become the mainstream recommended treatment for advanced gastric cancer. However, due to the heterogeneity of gastric cancer, part of some patients fail to benefit from the treatment. This project aims to compare the clinical efficacy of individualized neoadjuvant therapy based on patient-derived organoid drug sensitivity assay and traditional regimen, exploring the advantages and disadvantages of these two treatments. And access the safety and clinical value of the personalized neoadjuvant therapy based on patient-derived organoid drug sensitivity assay in advanced gastric cancer.

Being tested
PDO group, Traditional group
Keywords
advanced gastric carcinoma, patient-derived organoid, personalized treatment, Neoadjuvant Chemotherapy

What participants receive

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

  • PDO groupDrug

    Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. And they are treated with individualized neoadjuvant therapy under the guidance of a patient-derived organoid (PDO)-based drug sensitivity assay.

  • Traditional groupDrug

    Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. In this group, patients are treated with the SOX regimen.

Study groups in NCT05351398
Study groupRoleWhat they receive
PDO groupPatients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. And they are treated with individualized neoadjuvant therapy under the guidance of a patient-derived organoid (PDO)-based drug sensitivity assay.
Receives: Drug: PDO group; Drug: Traditional group
Traditional groupPatients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. In this group, patients are treated with the SOX regimen.
Receives: Drug: PDO group; Drug: Traditional group

What is being measured

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

  1. Objective Response Rate

    proportion of patients whose tumor volume reduced to a predetermined value and maintain the minimum time limit.

    Measured: an average of 1 year

Secondary outcomes (5)

  1. postoperative complication

    postoperative complication

    Measured: an average of 1 year

  2. postoperative tumor regression grading

    grade the pathological response of tumor after neoadjuvant treatment, which is usually classified according to the proportion of fibrosis and residual tumor in tumor tissues.

    Measured: an average of 1 year

  3. 3-year recurrence rate

    proportion of patients who relapse within 3 years after operation

    Measured: an average of 3 year

  4. chemotherapy tolerance and adverse reaction rate

    Measured: an average of 1 year

  5. R0 resection rate

    Measured: an average of 1 year

Timeline

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

  1. First posted28 Apr 2022
  2. Study startApr 2022 (estimated)
  3. Primary completionJun 2023 (estimated)
  4. Study completionDec 2023 (estimated)

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
Prospective
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05351398
Sponsor's protocol ID
MISC-WXXR-002
Status last verified
Apr 2022
First submitted
22 Apr 2022
Last updated
28 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021 Mar 17;134(7):783-791. doi: 10.1097/CM9.0000000000001474.

    PubMed 33734139

  • Kanaji S, Suzuki S, Matsuda Y, Hasegawa H, Yamamoto M, Yamashita K, Oshikiri T, Matsuda T, Nakamura T, Sumi Y, Kakeji Y. Recent updates in perioperative chemotherapy and recurrence pattern of gastric cancer. Ann Gastroenterol Surg. 2018 Aug 29;2(6):400-405. doi: 10.1002/ags3.12199. eCollection 2018 Nov.

    PubMed 30460342

  • Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.

    PubMed 16822992

  • Oh SY, Kwon HC, Jeong SH, Joo YT, Lee YJ, Cho Sh, Kang MH, Go SI, Lee GW, Kim Hg, Kang JH. A phase II study of S-1 and oxaliplatin (SOx) combination chemotherapy as a first-line therapy for patients with advanced gastric cancer. Invest New Drugs. 2012 Feb;30(1):350-6. doi: 10.1007/s10637-010-9507-2. Epub 2010 Aug 13.

    PubMed 20706861

  • Xu R, He X, Wufuli R, Su Y, Ma L, Chen R, Han Z, Wang F, Liu J. Choice of Capecitabine or S1 in Combination with Oxaliplatin based on Thymidine Phosphorylase and Dihydropyrimidine Dehydrogenase Expression Status in Patients with Advanced Gastric Cancer. J Gastric Cancer. 2019 Dec;19(4):408-416. doi: 10.5230/jgc.2019.19.e40. Epub 2019 Nov 13.

    PubMed 31897343

  • Vlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernandez-Mateos J, Khan K, Lampis A, Eason K, Huntingford I, Burke R, Rata M, Koh DM, Tunariu N, Collins D, Hulkki-Wilson S, Ragulan C, Spiteri I, Moorcraft SY, Chau I, Rao S, Watkins D, Fotiadis N, Bali M, Darvish-Damavandi M, Lote H, Eltahir Z, Smyth EC, Begum R, Clarke PA, Hahne JC, Dowsett M, de Bono J, Workman P, Sadanandam A, Fassan M, Sansom OJ, Eccles S, Starling N, Braconi C, Sottoriva A, Robinson SP, Cunningham D, Valeri N. Patient-derived organoids model treatment response of metastatic gastrointestinal cancers. Science. 2018 Feb 23;359(6378):920-926. doi: 10.1126/science.aao2774.

    PubMed 29472484

  • Driehuis E, Clevers H. CRISPR/Cas 9 genome editing and its applications in organoids. Am J Physiol Gastrointest Liver Physiol. 2017 Mar 1;312(3):G257-G265. doi: 10.1152/ajpgi.00410.2016. Epub 2017 Jan 26.

    PubMed 28126704

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Gastric Carcinoma, run by Shanghai Minimally Invasive Surgery Center 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 7 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 28 Apr 2022. 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.

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 Jin Sun, PhD (+86-21-64370045, sj11788@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: an average of 1 year). 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 NCT05351398, 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 28 Apr 2022.

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