Real-world Study of Triple Therapy for Intermediate-advanced HCC With BDTT (TALENP002)

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Combination Product: TACE, Lenvatinib, combined with Tislelizumab group

• Registration Number: NCT06602011
• Lead Sponsor: Fujian Provincial Hospital

Brief Summary

This is a multicenter, Single-arm, Real-world Study to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combined with Tislelizumab (Triple Therapy) for patients with Hepatocellular Carcinoma (HCC) with bile duct tumor thrombus (BDTT).

Detailed Description

Surgical resection is considered to be the treatment of choice for Hepatocellular Carcinoma (HCC) combined with bile duct tumor thrombus (BDTT), but a significant proportion of patients with HCC combined with BDTT are unable to undergo surgical treatment at the time of initial diagnosis. For patients with unresectable advanced HCC combined with BDTT, conversion therapy is particularly important. Currently, there is relatively little literature related to the conversion treatment of HCC with BDTT. Several studies have confirmed that the transcatheter arterial chemoembolization (TACE), lenvatinib, combined with Tislelizumab (Triple Therapy) for the treatment of intermediate-advanced HCC can achieve better efficacy with an acceptable safety. However, there are no clinical studies or relevant literature reports on Triple Therapy for the treatment of HCC with BDTT. The present study is a multicenter, Single-arm, Real-world Study designed to evaluate the efficacy and safety of a triple therapy for the treatment of patients with HCC with BDTT.

Study Timeline

• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-19
• Study Start: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-14
• Primary Completion: 2027-07-01
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age between 18 and 75 years old;
2. Patients with clinical diagnosis of Hepatocellular Carcinoma (HCC) combined with bile duct tumor thrombus (BDTT) (refer to the diagnostic criteria of the Chinese Expert Consensus on Multidisciplinary Diagnosis and Treatment of HCC with BDTT (2020 Edition)), BCLC Stage B or Stage C, and unresectable HCC (decided after multidisciplinary discussion);
3. Patients who had not received any tumor-related targeted, immunotherapy, radiotherapy and chemotherapy before enrollment;
4. Patients with at least one measurable lesion according to the mRECIST criteria (measurable lesion with a CT/MRI scan length diameter ≥ 10 mm and measurable lesion has not received localized treatment such as TACE, radiofrequency, cryotherapy, etc.);
5. ECOG score: 0-1;
6. liver function Child-Pugh class A or B; if combined with obstructive jaundice, total bilirubin ≤50umol/L is required. If higher than 50umol/L, biliary drainage is recommended;
7. Blood routine: absolute neutrophil count ≥1.5×10^9/L, Hb≥8.5g/L, PLT≥75×10^9/L;
8. No history of severe cardiac arrhythmia or heart failure; no history of severe ventilatory dysfunction or severe pulmonary infection; no acute or chronic renal failure with creatinine clearance >40mL/min;
9. Expected survival time greater than 3 months.

Exclusion Criteria

1. The tumor with extrahepatic metastasis or invaded adjacent organs;
2. Patients received other anti-tumor treatments;
3. Existence of contraindications to TACE;
4. History of allergy to the components or excipients of Lenvatinib or Tislelizumab;
5. The patient has any active autoimmune disease or has an autoimmune disease with expected relapse. Patients are on immunosuppressive or systemic hormone therapy for immunosuppression;
6. Patients with proteinuria suggestive of ≥ 1 + in routine urine will undergo a 24-hour urine protein test for patients with ≥ 1 g of 24-hour urine protein;
7. Patients with co-morbidities of other malignant tumors;
8. Patients with co-morbid psychiatric disorders;
9. Patients with pregnant or lactating women;
10. Patients with organ transplant patients;
11. Patients with hypothyroidism or hyperthyroidism.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Triple Therapy	TACE, Lenvatinib, combined with Tislelizumab group	-

Primary Outcome Measures

Name	Time	Method
Objective response rate, ORR	Four weeks after the initiation of medication until the day before surgery	The Objective response rate (ORR) was defined as the complete response (CR) rate or the partial response (PR) rate according to mRECIST.

Secondary Outcome Measures

Name	Time	Method
Overall survival, OS	From date of enrollment until the date of death from any cause, assessed up to 60 months	The Overall survival (OS) was defined as the time between receiving treatment and observing death or loss of follow-up for any reason.
Progression free survival, PFS	From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months	The Progression free survival (PFS) was defined as the time between the start of treatment and the progression of intrahepatic and/or extrahepatic tumors, or the occurrence of death or loss of follow-up for any reason.
The Disease control rate, DCR	Four weeks after the initiation of medication until the day before surgery	The Disease control rate (DCR) was defined as the complete response (CR) rate or the partial response (PR) rate or stable disease (SD) rate according to mRECIST.
Conversion resection rate, CRR	Four weeks after the initiation of medication until the day before surgery	The Conversion resection rate (CRR) was defined as the patient who reach the resectable criterion after treatment and accepted operation.
Toxicity Adverse events	From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 months	Grade 1-5 AEs according to NCI-CTCAE V5.0.

Trial Locations

Locations (6)

First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

Mengchao Hepatobiliary Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China

Zhongshan Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

Zhangzhou Affiliated Hospital of Fujian Medical University; 🇨🇳 Zhangzhou, Fujian, China