A Real-World Study of Neoadjuvant/Conversion Therapy for Locally Advanced or Metastatic Gastric Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorWuhan University

About this trial

Chemotherapy, immune checkpoint inhibitors, and anti-angiogenic targeted therapies have been explored in combination for neoadjuvant and conversion therapies. However, the efficacy of the novel anti-angiogenic agent fruquintinib in combination with immune checkpoint inhibitors and chemotherapy in the neoadjuvant and conversion treatment of locally advanced or metastatic gastric cancer has not been reported. This study aims to observe the efficacy and safety of fruquintinib combined with immune checkpoint inhibitors and chemotherapy in real-world settings.

Eligibility criteria

Qualifiers

Age ≥18 years and ≤75 years;

Either gender;

Disqualifiers

History of other primary malignant tumors, except: (1) complete remission of malignant tumors at least 2 years before enrollment and no need for other treatment during the study period; (2) adequately treated non-melanoma skin cancer or malignant melanoma without evidence of disease recurrence; (3) adequately treated in situ carcinoma.

Conversion therapy cohort: Diagnosis of HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Conversion therapy cohort: Evidence of distant metastases beyond oligometastases as defined in the inclusion criteria before the first dose of study treatment (such as brain, bone, etc.).

Female patients who are pregnant or lactating.

Trial design

Treatments tested in this trial

  • fruquintinib combined with immune checkpoint inhibitors and chemotherapy
  • fruquintinib combined with immune checkpoint inhibitors and chemotherapy

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators