Triple Therapy for Intermediate-advanced HCC With BDTT (TALENP002)

NCT06602011 | Recruiting

• 1 other identifier: TALENP002
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 6

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).

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; bile duct tumor thrombus; TACE; Lenvatinib; Tislelizumab

Outcome Measures

Primary Outcomes (1)

• Objective response rate, ORR

  The Objective response rate (ORR) was defined as the complete response (CR) rate or the partial response (PR) rate according to mRECIST.

  Four weeks after the initiation of medication until the day before surgery

Secondary Outcomes (5)

• Overall survival, OS

  From date of enrollment until the date of death from any cause, assessed up to 60 months

• 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 Disease control rate, DCR

  Four weeks after the initiation of medication until the day before surgery

• Conversion resection rate, CRR

  Four weeks after the initiation of medication until the day before surgery

• Toxicity Adverse events

  From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 months

Study Arms (1)

Triple Therapy

Combination Product: TACE, Lenvatinib, combined with Tislelizumab group

Interventions

TACE, Lenvatinib, combined with Tislelizumab group COMBINATION_PRODUCT

TACE, Lenvatinib \[8mg(\<60kg)/12mg(\>60kg) orally daily\] combination with Tislelizumab (200mg administered intravenous injection on Day 1 of each 21-day cycle). After the triple therapy, surgical resection is an option if assessed by the investigator to be feasible, or continued until disease progression or intolerable if not.

Triple Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intermediate-advanced Hepatocellular Carcinoma With Bile Duct Tumor Thrombus

You may qualify if:

• Age between 18 and 75 years old;
• 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);
• Patients who had not received any tumor-related targeted, immunotherapy, radiotherapy and chemotherapy before enrollment;
• 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.);
• ECOG score: 0-1;
• 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;
• Blood routine: absolute neutrophil count ≥1.5×10\^9/L, Hb≥8.5g/L, PLT≥75×10\^9/L;
• 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;
• Expected survival time greater than 3 months.

You may not qualify if:

• The tumor with extrahepatic metastasis or invaded adjacent organs;
• Patients received other anti-tumor treatments;
• Existence of contraindications to TACE;
• History of allergy to the components or excipients of Lenvatinib or Tislelizumab;
• 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;
• 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;
• Patients with co-morbidities of other malignant tumors;
• Patients with co-morbid psychiatric disorders;
• Patients with pregnant or lactating women;
• Patients with organ transplant patients;
• Patients with hypothyroidism or hyperthyroidism.

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (6)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

NOT YET RECRUITING

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, 350025, China

NOT YET RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, China

RECRUITING

Zhongshan Hospital of Xiamen University

Xiamen, Fujian, 361005, China

NOT YET RECRUITING

First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361021, China

NOT YET RECRUITING

Zhangzhou Affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, 363099, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Mao-Lin Yan

CONTACT

0591-88217140; yanmaolin74@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Hepatobiliary Pancreatic Surgery

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)