A Multi-national, Open-label, Randomized Phase II/III Clinical Study of Utidelone Capsule (UTD2) Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Summary

This is a multi-national, open-label, randomized, seamless phase II/III clinical study of UTD2 combined with fluoropyrimidine- and platinum-containing therapy to evaluate the efficacy and safety in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma untreated with systemic treatment in advanced setting.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

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
  Fluoropyrimidine- and Platinum-containing Therapy

  CAPOX: Capecitabine 1700 mg/m2/d, po, bid, d1-14，q3w, Oxaliplatin 130 mg/m2, iv, d1, q3w. After completing 6 times (18 weeks) of oxaliplatin treatment, the investigator may decide whether to continue oxaliplatin treatment for up to 8 times (24 weeks) based on the participant's benefits and safety. FOLFOX: Oxaliplatin 85 mg/m2, iv, d1, q2w. Folinic Acid 400 mg/m2, iv, d1, q2w, 5-FU 400 mg/m2 IV bolus d1 then 5-FU 2400 mg/m2 IV infusion over 46 to 48 hours, q2w. After completing 9 times (18 weeks) of treatment with oxaliplatin combined with folinic acid and 5-FU, the investigator may decide whether to continue FOLFOX treatment for up to 12 times (24 weeks) based on the participant's benefits and safety.

• Drug
  Oxaliplatin

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

Locations (10)