Clinical trial · Interventional
Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients
A Multi-center, Open-label, Phase II Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Savolitinib in Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients With MET Gene Amplifications
NCT04923932CI-TRIAL-00111258completedPhase 2ClinicalTrials.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)
Treating Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications with Savolitinib
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophagogastric Junction Disorder | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Savolitinib | Drug | Savolitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Savolitinib
- description
- GC
- interventionNames
- Drug: Savolitinib
Primary outcomes (1)
- measure
- Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria)
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months
- description
- To evaluate the efficacy of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications
Secondary outcomes (2)
- measure
- Progression-free survival (PFS) (RECIST 1.1 criteria)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure; 2. Age ≥18 years; 3. Histologically diagnosed locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma 4. MET gene amplifications 5. Cohort 1 \& 3: Having measurable lesions (in accordance with RECIST 1.1 criteria); Cohort 2: having evaluable lesions 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 7. Survival is expected to exceed 12 weeks; 8. Adequate functionality in bone marrow, liver, kidney 9. Able to take or swallow the drug orally. 10. Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 4 weeks after discontinuation of the study drug, The male patients whose sexual partners are women of childbearing age must use condom during sexual intercourse during the study and within 6 months after discontinuation of study drug; Exclusion Criteria: 1. Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years. Stage I malignant tumor after radical treatment for at least 3 years, except those considered by investigators to have small possibility of recurrence. Patients with radically treated carcinoma in situ (non-infiltrating) and skin cancer other than malignant melanoma can be enrolled; 2. Having received antitumor therapy (including chemotherapy, hormone therapy, biotherapy, immunotherapy or traditional Chinese medicine for antitumor indication) within 3 weeks prior to the start of study treatment, or having received treatment with small molecular tyrosine kinase inhibitors (e.g., EGFR-TKI) within 2 weeks prior to the start of study treatment; 3. Received extensive radiotherapy within 4 weeks of treatment 4. Received close distance radiotherapy within 60 days 5. Major surgery within 4 weeks of treatment 6. Taken strong CYP3A4 inducer within 2 weeks 7. Not recovered from past anti-tumor treatment toxicity 8. Active HIV infection 9. Active Hepatitis B or C infection
References
Publications (1)
- DERIVEDPeng Z, Liu T, Wang H, Wang J, Liu H, Ye F, Li E, Zhang J, Liu B, Lin R, Zhou A, Liu Z, Xu H, Wang Q, Niu Z, Yuan Y, Qin Y, Qu X, Bai Y, Liu N, Liu H, Bai C, Pan Y, Wang S, Wu T, Pan Q, Zhong D, Lu H, Wang J, Wang Z, Deng T, Gou H, Huang X, Fu S, Lu P, Yu J, Hong M, Xu Q, Wang L, Ren Y, Fan S, Shen L; Savolitinib in MET-amplified gastric or gastroesophageal junction adenocarcinoma study group. Savolitinib in MET-amplified gastric or gastroesophageal junction adenocarcinoma: a phase 2 trial. Nat Med. 2026 Aug;32(8):2888-2897. doi: 10.1038/s41591-026-04459-7. Epub 2026 Jun 1. PMID 42225990