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

NCT05351398 | Unknown

• 1 other identifier: MISC-WXXR-002
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Advanced Gastric Carcinoma

Keywords

advanced gastric carcinoma; patient-derived organoid; personalized treatment; Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

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

  an average of 1 year

Secondary Outcomes (5)

• postoperative complication

  an average of 1 year

• postoperative tumor regression grading

  an average of 1 year

• 3-year recurrence rate

  an average of 3 year

• chemotherapy tolerance and adverse reaction rate

  an average of 1 year

• R0 resection rate

  an average of 1 year

Study Arms (2)

PDO group

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.

Drug: PDO group; Drug: Traditional group

Traditional group

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.

Drug: PDO group; Drug: Traditional group

Interventions

PDO group DRUG

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.

PDO group; Traditional group

Traditional group DRUG

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.

PDO group; Traditional group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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:
• A. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Minimally Invasive Surgery Center: lead
• Ruijin Hospital: collaborator
• Shanghai OneTar Biomedicine Co., Ltd.: collaborator

Study Sites (1)

Shanghai Ruijin Hospttal

Shanghai, Sahnghai, 200000, China

Location

Related Publications (7)

• 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.

  PMID: 33734139 RESULT

• 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.

  PMID: 30460342 RESULT

• 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.

  PMID: 16822992 RESULT

• 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.

  PMID: 20706861 RESULT

• 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.

  PMID: 31897343 RESULT

• 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.

  PMID: 29472484 RESULT

• 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.

  PMID: 28126704 RESULT

Study Officials

• Jing Sun, PhD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Sun, PhD

CONTACT

+86-21-64370045; sj11788@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: April 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

CN (1)