Clinical trial · Observational
The Clinical Efficacy of Drug Sensitive Neoadjuvant Chemotherapy Based on Organoid Versus Traditional Neoadjuvant Chemotherapy in Advanced Gastric Cancer
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
NCT05351398CI-TRIAL-00058116unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Carcinoma | Gastric Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PDO group | Drug | — | UNRESOLVED |
| Traditional group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PDO group
- description
- 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.
- interventionNames
- Drug: PDO group
- Drug: Traditional group
- label
- Traditional group
- description
- 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.
- interventionNames
- Drug: PDO group
- Drug: Traditional group
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (7)
- RESULTCao 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
- RESULTKanaji 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
- RESULTCunningham 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
- RESULTOh 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
- RESULTXu 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
- RESULTVlachogiannis 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.