NCT05236699

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

Single-arm, Multicenter II Phase Clinical Study of DEB-TACE Combined With Surufatinib and Camrelizumab in the Treatment of Inoperable or Metastatic Intrahepatic Cholangiocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study design: This is a single-arm, open, multicenter II phase clinical study to compare the efficacy and safety of DEB-TACE combined with Surufatinib and Camrelizumab in the treatment of inoperable or metastatic ICC. Study population: 20 untreated patients with inoperable or metastatic intrahepatic cholangiocarcinoma Treatment: 1. All patients were treated with standard DEB-TACE on the first day (D1). 2. Immediately after the first DEB-TACE, the liver function was reexamined. If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1). 3. Surufatinib capsule was given orally to 250mg within 1 hour after breakfast on the second day (D2) after the first DEB-TACE. The drug was 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 continued until the patient developed the disease or met the other criteria for terminating the study. Curative effect evaluation： The tumor condition was evaluated by imaging method at D28 (±7 days) after each DEB-TACE, until the curative effect was evaluated as PD or unsuitable for further treatment. After 3 times of DEB-TACE treatment, the tumor efficacy was evaluated every 12 weeks (±7 days) from 6 months after the first DEB-TACE treatment until disease progression (Response Evaluation Criteria In Solid Tumors（RECIST）1.1) or death (during treatment) or toxicity intolerable. The tumor treatment and survival status after disease progression were recorded.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-01
• Primary completion: 2024-06-30
• Completion: 2025-01-31
• First posted: 2022-02-11
• Last updated: 2025-02-14

Locations

1 site across 1 country: China