Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC

Sponsor
Lei ZHAO
Study ID
NCT06296563
Phase
PHASE2
Status
Recruiting
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Conditions

  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

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

Interventions

  • HAIC — PROCEDURE
    FOLFOX-hepatic artery infusion for 2 times.
  • Adebrelimab — DRUG
    Adebrelimab 1200mg, ivgtt, d1, q3w,up to one year of use at most.
  • Apatinib — DRUG
    Apatinib 250mg, po, qd,q3w,up to one year of use at most.

Study Details

The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. The main question it aims to answer are: How to improve the survival of patients with intrahepatic cholangiocarcinoma and prolong the recurrence time after surgery. Participants will receive receive neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib for a maximum of one year.

Key Dates

Start date
Mar 1, 2024
Status verified
Apr 2024
Primary completion
Mar 1, 2027
Completion
Mar 1, 2029

Study Design

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

Arms

  • Experimental: HAIC+Adebrelimab+apatinib
    Neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib.

Primary Outcome Measure

Pathologic complete response (pCR) [ Time Frame: Up to one year ]

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