Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT05853172
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AK104 — DRUG
    Subjects will receive AK104 until disease progression or for up to 6 cycles.
  • Apatinib — DRUG
    Subjects will receive apatinib until disease progression or for up to 6 cycles.
  • Paclitaxel — DRUG
    Subjects will receive paclitaxel until disease progression or for up to 6 cycles.
  • S-1 — DRUG
    Subjects will receive S-1 until disease progression or for up to 6 cycles.

Study Details

This is a prospective, single-arm, open-label，single-center, phase II study, aiming to to evaluate the surgical conversion feasibility of AK104 combined with apatinib, paclitaxel and S-1 in unresectable stage IV G/GEJ cancer.

Key Dates

Start date
Mar 21, 2023
Status verified
Apr 2023
Primary completion
Mar 21, 2025
Completion
Dec 21, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AK104 plus apatinib, paclitaxel and S-1
    AK104 (10mg/kg, iv, Q3W) is combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis: 90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycle for up to 6 cycles.

Primary Outcome Measure

R0 surgical conversion rate [ Time Frame: up to 2 years ]

Central Contacts

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