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Gastrectomy+ chemotherapy
Gastrectomy+ chemotherapy is a Small molecule drug developed by Japan Clinical Oncology Group. It is currently in Phase 3 development for Locally advanced gastric cancer, Gastric adenocarcinoma amenable to curative resection.
Gastrectomy combined with chemotherapy removes the primary gastric tumor while systemic chemotherapy targets residual and metastatic cancer cells.
Gastrectomy combined with chemotherapy removes the primary gastric tumor while systemic chemotherapy targets residual and metastatic cancer cells. Used for Locally advanced gastric cancer, Gastric adenocarcinoma amenable to curative resection.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Gastrectomy+ chemotherapy |
|---|---|
| Sponsor | Japan Clinical Oncology Group |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This is a multimodal treatment approach for gastric cancer that combines surgical resection of the stomach (gastrectomy) with perioperative or adjuvant chemotherapy. The chemotherapy component typically uses platinum-based and fluoropyrimidine agents to eliminate micrometastatic disease and improve overall survival beyond surgery alone.
Approved indications
- Locally advanced gastric cancer
- Gastric adenocarcinoma amenable to curative resection
Common side effects
- Nausea and vomiting
- Myelosuppression
- Diarrhea
- Surgical complications (anastomotic leak, infection)
- Fatigue
Key clinical trials
- Gastroparesis Outcome Longitudinal Database Enrolled Numerically
- Laparoscopic Gastrectomy With D2 Lymphadenectomy Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Not (PHASE3)
- Impact Of Laparoscopic Sleeve Gastrectomy On Obesity-Related Comorbidities In Patients Over 65 Years (NA)
- Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study (PHASE2)
- Effect of Gabapentin on Kidney Function Following Laparoscopic Sleeve Gastrectomy(LSG) (PHASE4)
- Adebrelimab Combined With Induction Chemotherapy or SHR-8068 for Mismatch Repair-Deficient/Microsatellite Instability-High (dMMR/MSI-H) Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma：A Randomized, Non-comparative Phase 2 Study (PHASE2)
- Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer (PHASE2)
- Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Gastrectomy+ chemotherapy CI brief — competitive landscape report
- Gastrectomy+ chemotherapy updates RSS · CI watch RSS
- Japan Clinical Oncology Group portfolio CI
Frequently asked questions about Gastrectomy+ chemotherapy
What is Gastrectomy+ chemotherapy?
How does Gastrectomy+ chemotherapy work?
What is Gastrectomy+ chemotherapy used for?
Who makes Gastrectomy+ chemotherapy?
What development phase is Gastrectomy+ chemotherapy in?
What are the side effects of Gastrectomy+ chemotherapy?
Related
- Manufacturer: Japan Clinical Oncology Group — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Locally advanced gastric cancer
- Indication: Drugs for Gastric adenocarcinoma amenable to curative resection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing