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

Advanced Gastric Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05351398
• Other study ID #: MISC-WXXR-002
• Status: Not yet recruiting
• Start date: April 2022
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Shanghai Minimally Invasive Surgery Center
• Contact: Jin Sun, PhD
• Phone: +86-21-64370045
• Email: sj11788[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Advanced Gastric Carcinoma
• Stomach Neoplasms

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospttal	Shanghai	Sahnghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Minimally Invasive Surgery Center	Shanghai OneTar Biomedicine Co., Ltd., Wuxi Branch of Ruijin Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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 resect — View Citation

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. Review. — View Citation

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):400-40 — View Citation

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 — View Citation

Vlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernández-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, — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	postoperative complication	postoperative complication	an average of 1 year
Secondary	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.	an average of 1 year
Secondary	3-year recurrence rate	proportion of patients who relapse within 3 years after operation	an average of 3 year
Secondary	chemotherapy tolerance and adverse reaction rate		an average of 1 year
Secondary	R0 resection rate		an average of 1 year