Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients
May 8, 2026 updated by: Hutchison Medipharma Limited
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
Treating Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications with Savolitinib
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a single-arm, multi-cohort, multi-center, open-label, phase II clinical study.
The objective is to evaluate the efficacy and safety of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications.
The study involves a Screening Period, a Treatment Period and a Follow-up Period.
It had 54 study sites and enrolled/dosed 110 patients.
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China
- Beijing Cancer Hopspital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure;
- Age ≥18 years;
- Histologically diagnosed locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma
- MET gene amplifications
- Cohort 1 & 3: Having measurable lesions (in accordance with RECIST 1.1 criteria); Cohort 2: having evaluable lesions
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- Survival is expected to exceed 12 weeks;
- Adequate functionality in bone marrow, liver, kidney
- Able to take or swallow the drug orally.
- 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:
- 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;
- 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;
- Received extensive radiotherapy within 4 weeks of treatment
- Received close distance radiotherapy within 60 days
- Major surgery within 4 weeks of treatment
- Taken strong CYP3A4 inducer within 2 weeks
- Not recovered from past anti-tumor treatment toxicity
- Active HIV infection
- Active Hepatitis B or C infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Savolitinib
GC
|
Patients meeting the study inclusion criteria will receive Savolitinib [Savolitinib 600 mg, po, once per day (QD) continuously in patients with baseline weight ≥50 kg, and Savolitinib 400 mg, po, QD in patients with baseline weight <50 kg] in 21 day treatment cycle, until disease progression, death, intolerable toxicity or other termination criteria as specified in the protocol, whichever occurs earliest.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria)
Time Frame: 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
|
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
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free survival (PFS) (RECIST 1.1 criteria)
Time Frame: 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
|
Efficacy of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications
|
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
|
|
incidence of various adverse events (AE)
Time Frame: through study completion, an average of 3.5 year
|
To evaluate the safety and tolerability of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications
|
through study completion, an average of 3.5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lin Shen, MD, Peking University Cancer Hospital & Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 27, 2021
Primary Completion (Actual)
April 21, 2026
Study Completion (Actual)
April 21, 2026
Study Registration Dates
First Submitted
May 30, 2021
First Submitted That Met QC Criteria
June 10, 2021
First Posted (Actual)
June 11, 2021
Study Record Updates
Last Update Posted (Actual)
May 12, 2026
Last Update Submitted That Met QC Criteria
May 8, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-504-00CH1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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