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

NCT05236699 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-02-14

No results posted yet for this study

Summary

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.

Conditions

  • Intrahepatic Cholangiocarcinoma

Interventions

COMBINATION_PRODUCT

DEB-TACE combined with Surufatinib and Camrelizumab

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.

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Wanguang Zhang, M.D.,Ph.D. · Medical Ethics Committee of Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-06-30
Completion
2025-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05236699 on ClinicalTrials.gov