ClinicalTrials.gg
CompletedNCT04923932Updated May 12, 2026

Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients

A Phase 2 interventional study of Savolitinib in Gastric Cancer and Esophagogastric Junction Disorder, sponsored by Hutchison Medipharma Limited. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Hutchison Medipharma Limited (part of HUTCHMED) · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 1,183 studies in Stomach Neoplasms with a site in China — 480 open to participants now, 556 under way, 50 of them phase 3. Stomach Neoplasms · China.

Enrollment
367th of 880
110 · median 87
Started
2021
with 96 others
Phase 2
322 of 1,183
132 open now
Registered
521st of 1,183
by date

Among the 1,183 studies in Stomach Neoplasms with a site in China, this one is the 367th largest by enrollment of the 880 interventional ones that give a count, is one of 97 that started in 2021, is one of 322 in phase 2, and was the 521st registered.

Stomach Neoplasms

3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.

Browse Stomach Neoplasms studies →

Open to participants now

480 of the 1,183 studies in Stomach Neoplasms with a site in China are open now. Recruiting first, the newest first:

475 more — sign in →

All 480 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

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.

03

Conditions studied

  • Gastric Cancer
  • Esophagogastric Junction Disorder

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Fully aware this study and signed the form in voluntary manner, and willing and able to comply with the study procedure;
  2. Age ≥18 years;
  3. diagnosed locally advanced or Gastric Cancer and Esophagogastric junction adenocarcinoma
  4. MET gene amplifications
  5. Cohort 1 \& 3: Having (in accordance with 1.1 criteria); Cohort 2: having evaluable lesions
  6. (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 must agree to use effective 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

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 inducer within 2 weeks
  7. Not recovered from past anti-tumor treatment toxicity
  8. Active infection
  9. Active or C infection
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Savolitinib

    GC

    Drug: Savolitinib

Interventions

  • 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.

    Also known as: hmpl-504

06

What researchers measure

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. 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

    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

  2. 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

    Time frame: through study completion, an average of 3.5 year

07

Study locations

1 site
  • Beijing Cancer Hopspital
    Beijing, Beijing Municipality, China
08

References and documents

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 Jun 1. doi: 10.1038/s41591-026-04459-7. Online ahead of print. PubMed 42225990 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2021 to primary completion in Apr 2026, 56 months.

Of 65 industry-sponsored phase 2 interventional studies under Stomach Neoplasms, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 68. This study's 56 months is above that.

Counting every sponsor, half of 360 studies reached it within 50 months; a quarter within 31 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2021
First posted
Jun 11, 2021
StartActual
Jul 27, 2021
Primary completionActual
Apr 21, 2026
CompletionActual
Apr 21, 2026
Last update
May 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04923932
Responsible party
Sponsor
First posted
Jun 11, 2021
Start date
Jul 27, 2021
Primary completion
Apr 21, 2026
Completion
Apr 21, 2026
Last update
May 12, 2026

Study contacts

Lin Shen, MD
principal investigator · Peking University Cancer Hospital & Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Savolitinib

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