Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With 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.

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

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

Sponsors & Collaborators

• Beijing Biostar Pharmaceuticals Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-28

Primary Completion

2030-09-01

Completion

2030-09-01

FDA Drug

Yes

Countries

• United States
• China

Study Locations