NCT06841679

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

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 778 (estimated)
• Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
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
DRUG	Utidelone Capsule	UTD2 po, on d1-5, q3w (dose decided after the phase II)
DRUG	PD-1 inhibitor	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.
DRUG	Capecitabine	Capecitabine 1700 mg/m2/d po, bid, d1-14，q3w
DRUG	Capecitabine	Capecitabine, 2000 mg/m2/d, po, bid, d1-14, q3w

Timeline

• Start date: 2025-08-28
• Primary completion: 2030-09-01
• Completion: 2030-09-01
• First posted: 2025-02-24
• Last updated: 2025-11-25

Locations

10 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study