A Clinical Study of DEB-TACE Combined With Surufatinib and Camrelizumab in the Treatment of Inoperable or Metastatic ICC

Sponsor
Tongji Hospital
Study ID
NCT05236699
Phase
PHASE2
Status
Completed

Conditions

  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

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

Interventions

  • DEB-TACE combined with Surufatinib and Camrelizumab — COMBINATION_PRODUCT
    1. All patients will be treated with standard DEB-TACE on the first day (D1). 2. After DEB-TACE, if the liver function is Child-PughA grade, they will be treated with Camrelizumab on the same day, 200mg/ times, intravenous injection, once every 3 weeks. 3. Surufatinib capsule will be given orally to 250mg within 1 hour after breakfast on the second day (D2) after the first DEB-TACE. The drug will be given continuously once a day and stopped on the same day of each DEB-TACE. 4. The combination of drugs for 3 weeks is a cycle.The treatment will continue until the patient developed the disease or met the other criteria for terminating the study.

Study Details

At present, for advanced Intrahepatic Cholangiocarcinoma（ICC）, the effect of single treatment is not good.So far, superselective drug-eluting bead transarterial chemoembolization（DEB-TACE） is a good method for the treatment of local lesions in advanced ICC.Studies have shown that the combination of sovantinib and immunotherapy has also shown encouraging results, and patients are well tolerated.Therefore, we designed DEB-TACE combined with Surufatinib and Camrelizumab for the exploratory study of inoperable or metastatic ICC, in order to provide a safe, effective and tolerable option for patients with ICC, prolong their survival time and improve their quality of life.

Key Dates

Start date
Feb 1, 2022
Status verified
Feb 2025
Primary completion
Jun 30, 2024
Completion
Jan 31, 2025

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DEB-TACE combined with Surufatinib and Camrelizumab

Primary Outcome Measure

Objective remission rate (ORR) [ Time Frame: After the first DEB-TACE treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable，through study completion, an average of 1 year ]

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