Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

Conditions

• Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Utidelone Capsule — DRUG
  UTD2 40 mg/m2/d, po, qd, day 1-5, q3w
• Utidelone Capsule — DRUG
  50 mg/m2/d, po, qd, day 1-5, q3w
• Utidelone Capsule — DRUG
  60 mg/m2/d, po, qd, day 1-5, q3w
• Fluoropyrimidine- and Platinum-containing Therapy — DRUG
  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.
• Oxaliplatin — DRUG
  130 mg/m2/d, iv, day1, q3w, oxaliplatin will be given up to 6 cycles
• Utidelone Capsule — DRUG
  UTD2 po, on d1-5, q3w (dose decided after the phase II)
• PD-1 inhibitor — DRUG
  Whether to combine a PD-1 inhibitor will depend on the locally approved indications for the PD-1 inhibitor. If the participant's condition meets the locally approved indications for PD-1 inhibitors, the investigator may determine, in accordance with clinical guidelines, that the participant is eligible to receive treatment with UTD2 combined with fluoropyrimidine- and platinum-containing therapy, with or without a PD-1 inhibitor. If a PD-1 inhibitor is administered in combination, tislelizumab (200 mg), or pembrolizumab (200 mg), or nivolumab (360 mg), iv, day1, q3w. Alternatively, the investigator may select the dosage and administration cycle of other locally approved PD-1 inhibitors in accordance with the locally approved package inserts. The PD-1 inhibitor will be given up to 2 years.
• Capecitabine — DRUG
  Capecitabine 1700 mg/m2/d po, bid, d1-14，q3w
• Capecitabine — DRUG
  Capecitabine, 2000 mg/m2/d, po, bid, d1-14, q3w

Study Details

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.

Key Dates

Start date

Aug 28, 2025

Status verified

Nov 2025

Primary completion

Sep 1, 2030

Completion

Sep 1, 2030

Study Design

Enrollment

778 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1
  UTD2 40 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab )
• Experimental: Cohort 2
  UTD2 50 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab )
• Experimental: Cohort 3
  UTD2 60 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab )
• Experimental: Arm A
  UTD2 po, on d1-5, q3w (dose decided after the phase II) in combination with CAPOX
• Active Comparator: Arm B
  CAPOX

Primary Outcome Measure

Safety and tolerability of UTD2 and capecitabine in combination with oxaliplatin in Phase II [ Time Frame: From Day 1 to Day 21 ]

Central Contacts

• Rongguo Qiu
  010-56315388
  [email protected]

Locations (1)

Find similar trials in Hialeah, FL

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