Combination of Transcatheter Arterial Chemoembolization With Drug-eluting Beads, Lenvatinib and Anti-PD(L)1 Antibody for Downstaging Intrahepatic Cholangiocarcinoma for Radical Surgical Treatment

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Observational
SUMMARY

The aim of this study is to the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of Drug-eluting Beads-transarterial chemoembolization (DEB-TACE), lenvatinib, and anti-PD-1/ PD-L1 antibody for patients with advanced intrahepatic cholangiocarcinoma who were initially unsuitable for the radical therapy, including resection, transplantation, or ablation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Histologically confirmed intrahepatic cholangiocarcinoma.

• Age ≥18 years.

• ECOG performance status score of 0 or 1.

• Not suitable for radical surgery (including radical hepatic resection, liver transplantation or ablation) after evaluation by the MDT expert group of treating hepatobiliary cancer. Specifically, any of the following conditions are met:

‣ R0 resection is not feasible.

⁃ in subjects without cirrhosis, the volume of normal liver parenchyma is less than 30% of the total volume, or in patients with cirrhosis, the volume of normal liver parenchyma is less than 40% of the total volume, or ICG-R15\>15%.

⁃ Number of lesions \>1.

• No prior systemic anti-tumor treatment for intrahepatic cholangiocarcinoma before the first dose.

• According to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1), at least 1 measurable lesion, or a measurable lesion that has clearly progressed (based on RECIST V1.1 criteria) after local treatment.

• Subjects with portal vein tumor thrombus (PVTT):

‣ Chen's group A and B, or Cheng's type I-III can be enrolled.

⁃ Chen's group C, or Cheng's type IV (superior vena cava tumor thrombus) cannot be enrolled.

• Subjects with hepatic vein tumor thrombus:

‣ VV1 and VV2 types can be enrolled.

⁃ VV3 type, or Sakamoto type I (inferior vena cava tumor thrombus) can also be enrolled.

⁃ Sakamoto type II (inferior vena cava tumor thrombus extending above the diaphragm), or Sakamoto type III (inferior vena cava tumor thrombus reaching the right atrium) cannot be enrolled.

• Subjects with oligometastases outside the liver can be enrolled: Oligometastases outside the liver are defined as up to three metastatic lesions in a maximum of two organs, with the largest diameter being 3cm.

• Child-Pugh score less than or equal to 7.

• Adequate organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to inclusion (no blood components, cell growth factors, albumin, or other intravenous or subcutaneous corrective treatment drugs are allowed within 14 days prior to obtaining laboratory tests):

‣ Complete blood count: Absolute Neutrophil Count (ANC) ≥1.5×10\^9/L; Platelet count (PLT) ≥75×10\^9/L; Hemoglobin (HGB) ≥9.0 g/dL.

⁃ Liver function: Total Bilirubin (TBIL) ≤2×Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤5×ULN; Serum albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN.

⁃ Kidney function: Serum Creatinine (Cr) ≤ 1.5×ULN or Clearance of Creatinine (CCr) ≥50mL/min (Cockcroft-Gault formula); Urinalysis shows proteinuria \<2+; For subjects with baseline urinalysis showing proteinuria ≥2+, a 24-hour urine collection should be performed and 24-hour urinary protein quantification \<1g.

⁃ Coagulation function: International Normalized Ratio (INR) ≤2.3 or Prothrombin Time (PT) extension ≤6 seconds.

• Estimated life expectancy of ≥12 weeks.

• Female subjects of childbearing age or male subjects whose sexual partners are of childbearing age need to take effective contraceptive measures during the entire treatment period and for 6 months after the last medication.

Locations
Other Locations
China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Ze-yang Ding, M.D.
zyding@tjh.tjmu.edu.cn
+8613407156200
Backup
Han Gao
gh1023606887@163.com
+8617730117747
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 100
Treatments
DEB-TACE-len-anti-PD(L)1
Patients with advanced intrahepatic cholangiocarcinoma who was initially evaluated unsuitable for the radical therapy and received combined DEB-TACE plus lenvatinib (Len) and anti-PD1 or anti-PD-L1 antibodies as conversion therapy for downstaging.
Related Therapeutic Areas
Sponsors
Collaborators: Geneplus-Beijing Co. Ltd., Chinese Cooperative Group of Liver Cancer
Leads: Ze-yang Ding, MD

This content was sourced from clinicaltrials.gov

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