Adebrelimab Combined with Apatinib and Gemcitabine and Cisplatin (GP) First-line Treatment for Unresectable Biliary Tract Carcinoma

Sponsor
Henan Cancer Hospital
Study ID
NCT06749730
Phase
PHASE2
Status
Recruiting
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Conditions

  • Unresectable Biliary Tract Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab — DRUG
    adepelizumab ,1200mg, q3w
  • Apatinib — DRUG
    apatinib，250mg，QD
  • gemcitabine and cisplatin — DRUG
    cisplatin 25mg/m2，gemcitabine 1000mg/m2 d1,d8，q3w

Study Details

This study is designed to combine anti-angiogenic drugs on the basis of PD-L1+ gemcitabine/cisplatin, hoping to further improve the curative effect of advanced BTC treatment and provide more choices for first-line treatment of BTC in China.

Key Dates

Start date
Apr 1, 2024
Status verified
Jul 2024
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: adebrelimab combined with apatinib and gemcitabine and cisplatin

Primary Outcome Measure

Progression-free Survival [ Time Frame: From first dose of study intervention until disease progression or death (whichever occurs first), up to approximately 6 months after the last subject enrolled ]

Central Contacts