Fruquintinib Combined With PD-1 Inhibitor as First-line Maintenance Therapy for Advanced Gastric Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

This study was designed to explore the efficacy and safety of fruquintinib combined with PD-1 inhibitors as first-line maintenance therapy for advanced HER-2 Negative Gastric Cancer.

Eligibility criteria

Qualifiers

Voluntarily signed the informed consent and had good compliance;

Age ≥18 years, Eastern Cooperative Oncology Group (ECOG) score 0-1, and expected survival time ≥12 months;

Histologically or cytologically unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;

He had not received previous systemic chemotherapy for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma;

Disqualifiers

Participated in other drug clinical trials within 4 weeks before enrollment;

Have had other malignancies within the past 5 years, except cured basal cell carcinoma of the skin, papillary carcinoma of the thyroid, superficial bladder, carcinoma in situ of the breast, and carcinoma in situ of the cervix ;

History of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ grade 2 (NCI-CTCAE 5.0), heart failure ≥ grade 2 New York Heart Association (NYHA), transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, etc.

Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) and type 2 diabetes uncontrolled by antidiabetic treatment (fasting blood glucose ≥8.9mmol/L);

Trial design

Treatments tested in this trial

  • Initial treatment: PD-1+ Oxaliplatin-based chemotherapy (CAPOX/SOX/FOLFOX)
  • Maintenance treatment (after 3 months): fruquintinib+PD-1

Treatment groups

55 Participants
are divided into 1 treatment group

Sponsors and collaborators