Durvalumab Combined With Surufatinib as Maintenance Therapy in Patients With Advanced Biliary Tract Cancer

Sponsor
China Medical University, China
Study ID
NCT06255262
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surufatinib — DRUG
    (1) Safety introduction phase (6 cases): 250mg, oral, QD,after one cycle of combined treatment, the occurrence of DLT was evaluated: 1) If ≤1person occurs, continue the dose expansion study at that dose level. 2)In the event of DLT\> 1, then the dose of surufatinib was adjusted to 200mg，oral，QD,until disease progression or intolerance of toxicity. (2) Dose expansion phase (24 cases): RP2D, oral, QD,until disease progression or intolerance of toxicity.
  • Durvalumab — DRUG
    1500mg, Q4W.iv.every 28 days; until disease progression or intolerance of toxicity.

Study Details

A Real-World Study of Durvalumab combined with Surufatinib as maintenance therapy in patients with advanced biliary tract cancer whose disease did not progress after completion of first-line Durvalumab combined with Gemcitabine+cisplatin treatment.

Key Dates

Start date
Feb 15, 2024
Status verified
Feb 2024
Primary completion
Oct 31, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: Durvalumab in combination with surufatinib
    1. Safety introduction phase (6 cases) 2. Dose expansion phase (24 cases)

Primary Outcome Measure

Progress Free Survival 1 (PFS1) [ Time Frame: 2 years ]

Central Contacts

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