Gastric CancerPhase 2NCT04923932
Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients
A Phase 2 study testing Savolitinib in people with Gastric Cancer and Esophagogastric Junction Disorder, run by Hutchison Medipharma Limited at 1 site in China.
Trial summary
Treating Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications with Savolitinib Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Esophagogastric Junction Disorder
- What is being tested?
- Savolitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2021to 21 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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;
Who cannot join
- 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
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- Not recovered from past anti-tumor treatment toxicity
- Active HIV infection
- Active Hepatitis B or C infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Gastric Cancer, Esophagogastric Junction Disorder
- Being tested
- Savolitinib
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SavolitinibDrug
Also called hmpl-504
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.
| Study group | Role | What they receive |
|---|---|---|
| Savolitinib | Experimental | GC Receives: Drug: Savolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria)
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
Measured: 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 outcomes (2)
Progression-free survival (PFS) (RECIST 1.1 criteria)
Efficacy of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications
Measured: 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)
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
Measured: through study completion, an average of 3.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start27 Jul 2021
- Primary completion21 Apr 2026
- Study completion21 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications with measurable lesions OR with no measurable lesions but have evaluable lesions.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923932
- Sponsor's protocol ID
- 2020-504-00CH1
- Status last verified
- May 2026
- First submitted
- 30 May 2021
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peng 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.
PubMed 42225990
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04923932
- Acronym / sponsor ID
- 2020-504-00CH1
- Conditions
- Gastric Cancer, Esophagogastric Junction Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treating Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications with Savolitinib
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications with measurable lesions OR with no measurable lesions but have evaluable lesions.
| Arm | Type | Receives |
|---|---|---|
| Savolitinib | Experimental | Drug: SavolitinibGC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SavolitinibAlso: hmpl-504Patients 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. | Drug | Savolitinib |
Primary outcome
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
2 secondary outcomes
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
incidence of various adverse events (AE)
Time frame: through study completion, an average of 3.5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 42225990Peng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Shen, MD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Savolitinib in people with Gastric Cancer and Esophagogastric Junction Disorder, run by Hutchison Medipharma Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04923932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.