A Study of PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy in First-line Treatment of HER2-negative Advanced G/GEJ Cancer

Sponsor
Fudan University
Study ID
NCT06158919
Status
Recruiting
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Conditions

  • Gastric Cancer/Adenocarcinoma of Esophagogastric Junction

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、Capecitabine — DRUG
    Combined treatment period: A total of 6 cycles of combined treatment Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sintilimab: 200mg iv.gtt d1, q3w SOX : Oxaliplatin 130mg/m2 iv.gtt d1, Teysuno 40mg/m2 p.o.b.i.d. d1\~ 14q3w. Or XELOX regimen: oxaliplatin 130mg/m2 iv.gtt d1 Capecitabine 1000mg/m2 p.o. b.i.d. d1\~ 14q3w. Maintenance treatment period: Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sintilimab: 200mg iv.gtt d1, q3w Teysuno 40mg/m2 p.o.b.i.d. d1\~14 q3w or Capecitabine 1000mg/m2 p.o.b.i.d. d1\~14 q3w. Maintenance of treatment until disease progression or toxicity becomes intolerable.

Study Details

This is an open-label, single-arm, single-center clinical study to investigate the safety and efficacy of fuquinitinib combined with PD-1 inhibitors and first-line chemotherapy in the treatment of inoperable HER2-negative advanced GC/GEJC. Eligible enrolled patients received 6 cycles of combined treatment with fuquinitinib combined with PD-1 inhibitor and chemotherapy (XELOX/SOX) regimen. Maintenance treatment was fuquinitinib combined with PD-1 inhibitor and Teghio/capecitabine until disease progression or toxicity became intolerable. The longest duration of PD-1 inhibitor treatment is 24 months.

Key Dates

Start date
Nov 20, 2023
Status verified
Nov 2023
Primary completion
Nov 20, 2024
Completion
Nov 20, 2026

Study Design

Enrollment
58 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy
    Combined treatment period: A total of 6 cycles of combined treatment Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sindilizumab: 200mg iv.gtt d1, q3w SOX: Oxaliplatin 130mg/m2 iv.gtt d1, Teysuno 40mg/m2 p.o.b.i.d. d1\~ 14q3w. Or XELOX regimen: oxaliplatin 130mg/m2 iv.gtt d1 Capecitabine 1000mg/m2 p.o. b.i.d. d1\~ 14q3w. Maintenance treatment period: Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sindilizumab: 200mg iv.gtt d1, q3w Teysuno 40mg/m2 p.o.b.i.d. d1\~14 q3w or Capecitabine 1000mg/m2 p.o.b.i.d. d1\~14 q3w. Maintenance of treatment until disease progression or toxicity becomes intolerable.The longest duration of PD-1 inhibitor treatment is 24 months.

Primary Outcome Measure

PFS [ Time Frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]

Central Contacts