HAIC Combined With Sintilimab and Bevacizumab for Unresectable Intrahepatic Cholangiocarcinoma

Sponsor
Binkui Li
Study ID
NCT05400902
Phase
PHASE2
Status
Unknown

Conditions

  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

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

Interventions

  • HAIC Combined with Tislelizumab and Apatinib — DRUG
    Hepatic Arterial Infusion Chemotherapy: FOLFOX6 regimen was infused with chemotherapy drugs: oxaliplatin 130 mg/m2 infusion for 2 hours, folinate calcium 400 mg/m2 infusion for 2 hours, 5-fluorouracil 400 mg/m2 arterial infusion for 10 minutes, 5-fluorouracil 1200 mg/m2 infusion for 23 hours. Every 3 weeks, no more than 4 cycles of HAIC treatment. Sintilimab and Bevacizumab treatment: start at 0-3 days after the end of hepatic arterial infusion chemotherapy: Sintilimab 200 mg ivdrip, Q3W; Bevacizumab 15 mg/kg ivdrip, Q3W

Study Details

Primary liver cancer is the sixth most common cancer worldwide, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, of which intrahepatic cholangiocarcinoma accounts for 10%-15%. Surgical resection is the only curative method for ICC, but most patients are diagnosed at an advanced stage, and only 15% of patients can undergo surgical resection. In locally advanced ICC patients without distant metastases, although the tumor was initially assessed as unresectable, these patients may have the opportunity for surgical resection after reducing the size tumor lesion and increasing the remnant liver volume through conversion therapy. The current standard first-line treatment for unresectable ICC is gemcitabine combined with cisplatin, with a median overall survival of only 11.7 months and an ORR of 26.1%. In view of the poor effect of the standard chemotherapy regimen, the NCCN guidelines recommend that patients could participate in clinical study. Hepatic arterial infusion chemotherapy can increase the local blood drug concentration and improve the tumor regression rate. By reducing the dose of systemic chemotherapy drugs concentration, the incidence of adverse reactions can be reduced. Hepatic arterial infusion chemotherapy may be a better choice for locally advanced intrahepatic cholangiocarcinoma. PD-1 immunotherapy combined with targeted therapy is expected to improve the prognosis of patients with intrahepatic cholangiocarcinoma. This study investigates the safety and efficacy of hepatic arterial infusion chemotherapy combined with sintilimab and bevacizumabin the treatment of unresectable ICC.

Key Dates

Start date
May 31, 2023
Status verified
Apr 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

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

Arms

  • Experimental: HAIC Combined with Sintilimab and Bevacizumab

Primary Outcome Measure

Response Rate [ Time Frame: 12 months ]

Central Contacts

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