Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients

Last updated: May 8, 2026
Sponsor: Hutchison Medipharma Limited
Overall Status: Completed

Phase

2

Condition

Digestive System Neoplasms

Gastric Cancer

Adenocarcinoma

Treatment

Savolitinib

Clinical Study ID

NCT04923932
2020-504-00CH1
  • Ages > 18
  • All Genders

Study Summary

Treating Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications with Savolitinib

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Fully aware this study and signed the informed consent form in voluntary manner, andwilling and able to comply with the study procedure;

  2. Age ≥18 years;

  3. Histologically diagnosed locally advanced or metastatic Gastric Cancer andEsophagogastric 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 contraceptivemethods from screening period to 4 weeks after discontinuation of the study drug,The male patients whose sexual partners are women of childbearing age must usecondom during sexual intercourse during the study and within 6 months afterdiscontinuation of study drug;

Exclusion

Exclusion Criteria:

  1. Currently having other malignant tumors, or having other infiltrating malignanttumors in the past 5 years. Stage I malignant tumor after radical treatment for atleast 3 years, except those considered by investigators to have small possibility ofrecurrence. Patients with radically treated carcinoma in situ (non-infiltrating) andskin 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 treatmentwith small molecular tyrosine kinase inhibitors (e.g., EGFR-TKI) within 2 weeksprior 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

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: Savolitinib
Phase: 2
Study Start date:
July 27, 2021
Estimated Completion Date:
April 21, 2026

Study 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.

Connect with a study center

  • Beijing Cancer Hopspital

    Beijing, Beijing Municipality
    China

    Site Not Available

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