Utidelone Capsule Combined with Capecitabine and Oxaliplatin in First-line Treatment of PD-L1-negative Gastric or Gastroesophageal Junction Adenocarcinoma Patients

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

778

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

September 1, 2030

Study Completion Date

September 1, 2030

Conditions
Gastric or Gastroesophageal Junction Adenocarcinoma
Interventions
DRUG

Utidelone Capsule

UTD2 40 mg/m2/d, po, qd, day 1-5, q3w

DRUG

Utidelone Capsule

50 mg/m2/d, po, qd, day 1-5, q3w

DRUG

Utidelone Capsule

60 mg/m2/d, po, qd, day 1-5, q3w

DRUG

Capecitabine

1000 mg/m2, po, bid, day 1-14, q3w

DRUG

Oxaliplatin

130 mg/m2/d, iv, day1, q3w, oxaliplatin will be given up to 6 cycles

DRUG

Utidelone Capsule

UTD2 po, on d1-5, q3w (dose decided after the phase II)

All Listed Sponsors
lead

Beijing Biostar Pharmaceuticals Co., Ltd.

INDUSTRY